CLINICAL PAPERS
Efficacy of Intense Pulsed Light for the Treatment of Burn Scar Dyschromias A Pilot Study to Assess Patient Satisfaction, Safety, and Willingness to Pay Charles Scott Hultman, MD, MBA, FACS, Jonathan S. Friedstat, MD, and Renee E. Edkins, NP, DNP Introduction: No treatment algorithms exist to reliably treat burn scar dyschromias. Intense pulsed light (IPL) has been used successfully to treat hyperpigmentation disorders, but has not been studied extensively in the treatment of burn scars. The purpose of this investigation was to assess clinical efficacy and patient satisfaction with IPL for the treatment of burn scar dyschromia. Methods: Patients with burn scar dyschromias were treated using the Lume 1 platform (Lumenis) to target pigmented lesions, using fluences between 10 and 22 joules/cm2 and filters ranging from 560 to 650 nm. At the conclusion of the study, providers assessed changes in burn scar dyschromia, whereas patients were queried regarding satisfaction and perceived efficacy, using a 1 to 5 Likert scale. The patients, who were not charged for the IPL treatment, were queried regarding willingness to pay. Results: Twenty patients (mean age, 35.4 years; mean total body surface area, 27.6%; mean composite Fitzpatrick score, 3.9) underwent IPL treatment of burn scar dyschromias, an average of 3.2 years after injury. Mean fluence was 15.4 J/cm2 (range, 10–22 J/cm2), and the most common filter used was 590 nm (range, 560–650 nm). Mean area treated was 90.7 cm2, with a range of 4 to 448 cm2. Complications included pain (4), hyperpigmentation (1), and blistering (2). Sixteen patients noted mild to moderate improvement, reporting a 4.5 for efficacy and a 4.4 for satisfaction. Regarding willingness to pay, patients would spend a mean of U.S. $7429 to completely remove their scars, but only a median of U.S. $350 to get the actual results that they received. Mean length of follow-up was 3.8 months, with a standard deviation of 2.2 months. Conclusions: Patients perceived IPL as an efficacious modality in the treatment of burn scar dyschromia, with a high level of satisfaction, despite the potential for morbidity. However, we are reluctant to recommend IPL for routine treatment of burn scar dyschromias, given only minimal improvement observed, potential for complications, and a willingness to pay that is lower than the cost of providing care. Key Words: burn scar, dyschromia, intense pulsed light (Ann Plast Surg 2015;74: S204–S208)
P
atients who develop scarring after burn injury are also at risk for disorders of pigmentation, otherwise known as dyschromias, due to damage of melanocytes and hair follicles in the various layers of the epidermis and dermis. In addition to potentially causing hypertrophic
Received November 1, 2014, and accepted for publication, after revision, December 16, 2014. From the Division of Plastic Surgery, University of North Carolina Health Care System, Chapel Hill, NC. Presented as a Member Paper at the 57th Annual Scientific Meeting of the SESPRS, June 8-12, 2014, Nassau, Bahamas SESPRS 2014 ANNUAL MEETING PAPER Conflict of interest and sources of funding: Ethel and James Valone Plastic Surgery Research Endowment. Reprints: Charles Scott Hultman, MD, MBA, FACS, Ethel and James Valone Distinguished Professor of Surgery, Chief and Program Director, Division of Plastic Surgery, Suite 7038, Burnett-Womack, CB 7195, University of North Carolina, Chapel Hill, NC 27599-7195. E-mail: [email protected]. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0148-7043/15/7404–S204 DOI: 10.1097/SAP.0000000000000447
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scars, keloids, contractures, and unstable wounds, thermal injury can lead to problems of abnormal texture, distortion of anatomic landmarks and borders, and hyperpigmentation and hypopigmentation.1–3 Although these latter conditions are not as functionally problematic as pathologic scar formation, the esthetic considerations can be quite distressing to the patient and may yield severe psychological sequelae. Options for improving burn scar dyschromia are limited. Although some modalities, such as topical steroids, hydroquinone, and retinoids, can reduce hyperpigmentation in the setting of nonthermal etiologies, no algorithms have been developed to treat burn patients with altered pigmentation. Over the past decade, advances in laserand light-based technologies have allowed providers to treat hypertrophic burn scars and achieve results not previously possible, through the delivery of energy that targets abnormal chromophores and induces remodeling of abnormal collagen in the dermis.4–12 Intense pulsed light (IPL) is an alternative platform that has documented efficacy in treating pigmentation disorders, such as melasma and solar elastosis, as well as hypertrichosis, chronic folliculitis, striae distensae, acne scarring, and photoaging.13–23 Few publications have explored the effect of IPL on hypertrophic scar formation, and only 2 reports have specifically addressed the use of IPL to treat burn scar abnormalities.24,25 The purpose of this investigation was to assess patient satisfaction, safety, and clinical efficacy of IPL for the treatment of burn scar dyschromia.
METHODS Study Design This investigation was a nonrandomized, noncontrolled, singlecohort, descriptive study, undertaken as a pilot project, to assess the safety and efficacy of IPL therapy for burn scars with mixed or hyperpigmentation. Patients presenting for consultation regarding management of burn scar dyschromia were invited to participate if they met the following criteria: were able to provide consent or have a parent provide consent; were at least 6 months after burn injury; had no open wounds in the area to be treated; were not presently using (or had in the previous 6 months used) topical lightening agents, retinoids, or corticosteroids; and had not undergone dermabrasion or chemical peels of the areas to be treated. Up to 2 sessions with the Lume One IPL platform (Lumenis, Santa Clara, CA) were provided free of charge, as an incentive to participate in the study.
Study Approval The University of North Carolina Biomedical Institutional Review Board approved this project as IRB Study 11-0946, under the title “Laser and/or Light Based Therapy for the Management of Hypertrophic, Hyperemic, or Dyschromic Burn Scars.”
Study Setting Patients were treated in an office-based setting, at the University of North Carolina. Referrals for treatment were received from the North Annals of Plastic Surgery • Volume 74, Supplement 4, June 2015
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Annals of Plastic Surgery • Volume 74, Supplement 4, June 2015
IPL for Burn Scar Dyschromias
TABLE 1. Definitions of Fitzpatrick Skin Type Skin type
Burn Potential
Tan Potential
Skin Color
I II III IV V VI
Always Always easily Moderately Minimally Rarely Never
Never Minimally Uniformly Always Profusely Deeply pigmented
Pale white White Light brown Moderate brown Dark brown Black
Carolina Jaycee Burn Center, an accredited, verified burn center in the southeastern United States, which services a 6-state region (NC, SC, GA, WV, VA, TN).
Outcome Measures Participants were asked to assess the effect of IPL on their burn scar pigmentation, approximately 8 weeks after receiving treatment, using a 5-point Likert scale (5, significantly improved; 4, slightly improved; 3, no change; 2, slightly worse; 1, significantly worse). Additionally, participants were queried on their overall satisfaction with the treatment (5, very satisfied; 4, slightly satisfied; 3, neutral satisfaction; 2, slightly unsatisfied; 1, very unsatisfied). Patients were also asked if they would recommend such a procedure to another burn patient (yes/no) and if they would repeat the experience again (yes/no). Finally, we asked patients 2 questions about willingness to pay for the procedure: (1) how much money would you pay to completely remove your burn scars? And (2) how much money would you pay for your actual results?
RESULTS Twenty patients, with a mean age 35.4 years (range, 4–61; SD, 18.6) and a mean total body surface area burn of 27.6% (range, 1–90; SD, 29.0), underwent IPL treatment of burn scar dyschromia. Locations treated included face (n = 10), neck (n = 8), chest (n = 7), upper extremities (n = 12), lower extremities (n = 10), hands (n = 4), and abdomen (n = 1), with most patients having multiple anatomic sites treated. Patients had a mean composite Fitzpatrick score of 3.9, with a median and mode of 4 (range, 1–6). The cohort included 11 female and 9 male patients. Grading of Fitzpatrick score is listed in Table 1.26 The authors transcribed the composite scores of I to VI to 1 to 6. Regarding mechanism of burn injury, the distribution was as follows: flame (n = 9), scald (n = 5), contact (n = 3), electrical flash (n = 1), friction (n = 1), and ultrasound (n = 1). The IPL treatment occurred a mean of 3.2 years after injury (range, 1.0–15.2; median,
FIGURE 1. Improvement in burn scar hyperpigmentation, after 1 IPL session, in a patient with posttraumatic dyschromia of hand, wrist, and forearm. © 2015 Wolters Kluwer Health, Inc. All rights reserved.
FIGURE 2. A 24-year-old woman, after scald injury to her right arm, with minimal improvement in burn scar dyschromia, after 1 IPL session (preop on left, postop on right).
1.9; SD, 3.8). Mean length of follow-up was 3.8 months, with a standard deviation of 2.2 months and a range of 2 weeks to 6.8 months. Mean fluence used for the IPL treatment was 15.4 J/cm2 (range, 10–22 J/cm2), and the most common filter used was 590 nm (range, 560–650 nm). Mean area treated was 90.7 cm2, with a range of 4 to 448 cm2 and an SD of 118 cm2. Of the 20 patients, 17 had 1 session and 3 had 2 sessions. Seven patients experienced complications (35%), which include procedural and postprocedural pain (n = 4), postinflammatory hyperpigmentation (n = 1), mild blistering (n = 1), and moderate blistering (n = 1). Sixteen patients noted mild to significant improvement, reporting a 4.5 for efficacy, and a 4.4 for satisfaction. However, 1 patient who reported a 4 for efficacy, noted a 2 for satisfaction. Eleven patients noted that they would repeat the procedure if given the chance, and 13 patients would recommend the procedure to other burn patients with dyschromia. Regarding willingness to pay, patients indicated that they would spend a mean of U.S. $7429 (SD, U.S. $3756) to completely remove their scars (median, U.S. $10,000), but would spend only a mean of U.S. $1200 (SD, U.S. $2664) and to get the actual results that they received (median, U.S. $350). Economic utility of IPL, based on mean willingness to pay, would be U.S. $1200/ U.S. $7249 (or 17%). Based on median willingness to pay, economic utility drops to U.S. $350/U.S. $10,000 (or 4%). Sample patients are shown in Figures 1–4.
DISCUSSION In this pilot study of 20 patients undergoing IPL treatment for burn scar dyschromia, 16 (80%) reported mild to moderate improvement of hyperpigmentation, despite a complication/adverse event rate of 35%, which included procedural and postoperative pain, blistering, and 1 case of postinflammatory hyperpigmentation. One patient who failed to improve did have significant resolution of post-burn erythema with multiple, successive treatments, using a 595-nm PDL. Interestingly, although patients reported a 4.5 for efficacy and a 4.4 for satisfaction, using 1 to 5 Likert scale, their willingness to pay was fairly low. Even though patients would be willing to spend a mean of $7429 to completely remove their scars, they would only offer a median of $350 to get the actual results that they received, placing this procedure in a category of poor economic utility. This contrasts dramatically with previous “willingness to pay” data that we published, regarding use of lasers to treat hypertrophic burn scars, in which patients reported an economic utility of 84.8%.4 These patients were posed the scenario: if given a million dollars, how much money would you spend to completely remove your burn scars, and how much money would you spend to get your actual results. www.annalsplasticsurgery.com
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FIGURE 3. A 45-year-old woman, after grease burn to head, neck, and chest, after 2 IPL sessions, with moderate improvement of forehead but hyperpigmentation of chin and cheek (preop on left, postop on right). Superficial fractional CO2 laser resurfacing, in combination with a topical regimen of corticosteroid/hydroquinone/tretinoin, was required to improve this case of post-inflammatory hyperpigmentation (results not shown).
In terms of long-term patient satisfaction, patients who underwent PDL photothermolysis and fractional CO2 ablation of hypertrophic burn scars indicated that the treatments yielded moderate to definite improvement (mean of 4.78 on a 1–5 Likert scale), corresponding to a drop in Vancouver Scar Score from 10.43 to 5.16 (4 months after treatments) to 3.29 (25 months after treatments). Furthermore, they were
willing to part with $331,308 to eliminate their burn scars, and the patients would pay U.S. $2,220,356 to achieve the long-term results that they had, producing the economic utility of 84.8%. An objective provider assessment was not performed in the current study. However, the subjective interpretation of the authors was that IPL reduced hyperpigmentation in some cases, but these results were not predictable, consistent, or long-lasting. The most impressive case of improvement ironically came in a patient whose mixed forehead pigmentation became more confluent and less irregular, but who also developed hyperpigmentation in a separate site. She subsequently required superficial fractional CO2 ablative resurfacing to downregulate melanocyte production, in combination with a topical regimen of hydroquinone and tretinoin. Intense pulsed light is a relatively new technology, in which intense flashes of noncoherent light, distributed over a range of wavelengths from 500 nm to 1200 nm (depending on the cutoff filter used to block the lower spectrum of wavelengths), are directed at target chromophores in the skin.13 The result is somewhat nonspecific disruption of the targets, via transfer of energy and generation of heat; favorable targets include hair follicles and melanocytic lesions, because these chromophores are susceptible to the selected wavelengths, whereas other epidermal, dermal, and subdermal elements are relatively spared. Aesthetic indications include photoaging with solar elastosis, melasma, hypertrichosis, unwanted hair, chronic folliculitis, rosacea, striae distensae, and acne scarring.14–23 Over the past 10 years, management of hypertrophic burn scars has undergone a paradigm shift, moving from excision of the scar to modulation of existing scar, through the extensive remodeling can be effected by the use of new and developing laser-based technologies.1–12 Unlike IPL, lasers are coherent, monochromatic, and collimated, allowing
FIGURE 4. A 53-year-old man, who sustained a flame burn to face and chest, following one session of IPL, with minimal-to-no effect, and subsequent sessions with pulsed-dye laser, which did improve erythema (patient data not included in current study) (preoperative is on top, postoperative is on bottom). S206
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Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Annals of Plastic Surgery • Volume 74, Supplement 4, June 2015
the provider to precisely target abnormal chromophores in burned skin, which contains neovascularized scar, disorganized collagen, and pathologic fibroblasts and myofibroblasts. The current practice is to use pulsed-dye laser photothermolysis for immature, hypervascular, red scars (which may be painful and pruritic) and to use fractional CO2 laser ablation to decrease the thickness and improve the pliability of more mature, hypertrophic scars.4,11 Prediction and control of final pigmentation is quite difficult, especially in patients with increasing Fitzpatrick skin types. Current protocols include the use of topical corticosteroids, hydroquinone, and tretinoin, over the course of several months. Application of sunblock is critical during and after this period, as ultraviolet radiation stimulates melanocytes, and improvements in hyperpigmentation typically lessen over time, resulting in recurrent dyschromia. Intense pulsed light is an intriguing technology that could theoretically help in the management of post-burn hyperpigmentation. Despite fairly good evidence that IPL improves other aesthetic conditions, very little literature exists to support the use of IPL for burn scar dyschromia. In a prospective study from 2003, Ho et al24 reported that IPL resulted in a 50% clinical improvement in 15 of 19 Chinese patients, with a follow-up of 11 to 32 months. Two patients had no response, and 4 of the 19 patients, or 21.2%, developed complications of blistering or erythema. Since then, no other reports focusing on the IPL treatment of burn scar dyschromia have been published. The only other report that includes a significant number of burn patients, whose scars were treated by IPL, came from Erol et al25 in 2008. The authors studied the effect of IPL on height, erythema, hardness, and appearance, in 109 patients with surgical incisions (n = 55), traumatic lacerations and abrasions (n = 24), acne scars (n = 6), keloids (n = 5), and burns (n = 19), treated across an average of 8 sessions. Although they reported improvement in 92.5% of patients, in at least 1 measurable outcome, the authors did not specifically study dyschromia—the degree of pigment in the skin—nor did they perform a subgroup analysis of burn patients. Their use of IPL more closely approximates our use of PDL to treat hypertrophic, hyperemic scars. Despite relatively high patient satisfaction, with mild to moderate improvement in 80% of our patients, we do not recommend the routine use of IPL for the treatment of burn scar dyschromia. Some carefully selected patients may benefit from this modality, but managing patient expectations and avoiding patient complications are both critical. For a noninvasive, relatively safe laser/light platform, IPL can generate significant complications or adverse sequelae,27–29 perhaps due to the nonspecific nature of this energy source and the increased likelihood of producing collateral damage at a fluence required to downregulate burn scar melanocytes. Certainly, the use of IPL in patients with increased pigmentation, in the setting of a high Fitzpatrick skin type, should be done very cautiously. Other aspects of IPL which preclude us from recommending this therapy to treat burn scar hyperpigmentation include: (1) the variable efficacy observed in our limited patient population; (2) the need for multiple sessions to produce the response desired by the patient; (3) efficacy which appears to be similar to that of topical agents such as corticosteroids, hydroquinone, and tretinoin, 4) and probable recurrence of hyperpigmentation with ultraviolet light exposure, which is a well-documented limitation of IPL, when used for other cosmetic indications. The final consideration, which argues against the use of IPL for burn scar dyschromia, is economic. Because almost all insurance companies rightfully view burn scar dyschromia as cosmetic and do not reimburse for IPL, we do not believe that it is fair or responsible to charge burn patients the prices that the aesthetic market supports for other IPL treatments. Current charges, for a single session, range from U.S. $150 for a small area on the trunk, to U.S. $550 for both hands, to U.S. $1050 for the entire neck and face. The perceived value to our patients is certainly below what they would be willing to pay, given that they reported a “willingness to pay” of only U.S. $350, in a hypothetical model, in © 2015 Wolters Kluwer Health, Inc. All rights reserved.
IPL for Burn Scar Dyschromias
which they did not actually have to pay for the treatment. Furthermore, the actual price point at which the patient would assume responsibility for payment resides below the variable and overhead costs to provide that care. Because IPL has inconsistent efficacy, requires multiple sessions, yields results that are not lasting, is not superior to topical agents, and has the potential to produce real complications, we do not recommend the routine use of IPL for the treatment of burn scar dyschromia. ACKNOWLEDGMENT Informed consent has been received for publication of the figures in this article. REFERENCES 1. Tredgett EE, Levi B, Donelan MB. Biology and principles of scar management and burn reconstruction. Surg Clin N Am. 2014;94:793–815. 2. Cartotto R, Cicuto BJ, Kiwanuka HN, et al. Common postburn deformities and their management. Surg Clin N Am. 2014;94:817–837. 3. Friedstat JS, Hultman CS. Hypertrophic burn scar management: what does the evidence show? A systematic review of randomized controlled trials. Ann Plast Surg. 2014;72:S198–S201. 4. Hultman CS, Friedstat JS, Edkins RE, et al. Laser resurfacing and remodeling of hypertrophic burn scars: the results of a large, prospective, before-after cohort study, with long-term follow-up. Ann Surg. 2014;260:519–529; discussion 529–32. 5. Hultman CS, Edkins RE, Wu C, et al. Prospective, before-after cohort study to assess the efficacy of laser therapy on hypertrophic burn scars. Ann Plast Surg. 2013;70:521–526. 6. Taudorf EH, Danielsen PL, Paulsen IF, et al. Non-ablative fractional laser provides long-term improvement of mature burn scars-A randomized controlled trial with histological assessment. Lasers Surg Med. 2014. [Epub ahead of print]. 7. Khandelwal A, Yelvington M, Tang X, et al. Ablative fractional photothermolysis for the treatment of hypertrophic burn scars in adult and pediatric patients: a single surgeon's experience. J Burn Care Res. 2014;35:455–463. 8. Waibel JS, Wulkan AJ, Shumaker PR. Treatment of hypertrophic scars using laser and laser assisted corticosteroid delivery. Lasers Surg Med. 2013;45:135–140. 9. Ozog DM, Liu A, Chaffins ML, et al. Evaluation of clinical results, histological architecture, and collagen expression following treatment of mature burn scars with a fractional carbon dioxide laser. JAMA Dermatol. 2013;149:50–57. 10. Bailey JK, Burkes SA, Visscher MO, et al. Multimodal quantitative analysis of early pulsed-dye laser treatment of scars at a pediatric burn hospital. Dermatol Surg. 2012;38:1490–1496. 11. Anderson RR, Donelan MB, Hivnor C, et al. Laser treatment of traumatic scars with an emphasis on ablative fractional laser resurfacing: consensus report. JAMA Dermatol. 2014;150:187–193. 12. Donelan MB, Parrett BM, Sheridan RL. Pulsed dye laser therapy and z-plasty for facial burn scars: the alternative to excision. Ann Plast Surg. 2008;60:480–486. 13. Wat H, Wu DC, Rao J, et al. Application of intense pulsed light in the treatment of dermatologic disease: a systematic review. Dermatol Surg. 2014;40:359–377. 14. Shamsi Meymandi S, Rezazadeh A, Ekhlasi A. Studying intense pulsed light method along with corticosteroid injection in treating keloid scars. Iran Red Crescent Med J. 2014;16:e12464. 15. Vrijman C, van Drooge AM, Limpens J, et al. Laser and intense pulsed light therapy for the treatment of hypertrophic scars: a systematic review. Br J Dermatol. 2011;165:934–942. 16. Piccolo D, Di Marcantonio D, Crisman G, et al. Unconventional use of intense pulsed light. Biomed Res Int. 2014;2014:618206. 17. Ozdemir M, Engin B, Mevlitoğlu I. Treatment of facial port-wine stains with intense pulsed light: a prospective study. J Cosmet Dermatol. 2008;7:127–131. 18. Bellew SG, Weiss MA, Weiss RA. Comparison of intense pulsed light to 595-nm long-pulsed pulsed dye laser for treatment of hypertrophic surgical scars: a pilot study. J Drugs Dermatol. 2005;4:448–452. 19. Wang B, Wu Y, Luo YJ, et al. Combination of intense pulsed light and fractional CO(2) laser treatments for patients with acne with inflammatory and scarring lesions. Clin Exp Dermatol. 2013;38:344–351. 20. Trelles MA, Levy JL, Ghersetich I. Effects achieved on stretch marks by a nonfractional broadband infrared light system treatment. Aesthetic Plast Surg. 2008;32:523–530. 21. Hedelund L, Due E, Bjerring P, et al. Skin rejuvenation using intense pulsed light: a randomized controlled split-face trial with blinded response evaluation. Arch Dermatol. 2006;142:985–990.
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22. Hernández-Pérez E, Colombo-Charrier E, Valencia-Ibiett E. Intense pulsed light in the treatment of striae distensae. Dermatol Surg. 2002;28:1124–1130. 23. Cao Y, Huo R, Feng Y, et al. Effects of intense pulsed light on the biological properties and ultrastructure of skin dermal fibroblasts: potential roles in photoaging. Photomed Laser Surg. 2011;29:327–332. 24. Ho WS, Chan HH, Ying SY, et al. Prospective study on the treatment of postburn hyperpigmentation by intense pulsed light. Lasers Surg Med. 2003;32: 42–45. 25. Erol OO, Gurlek A, Agaoglu G, et al. Treatment of hypertrophic scars and keloids using intense pulsed light (IPL). Aesthetic Plast Surg. 2008;32:902–909.
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26. Fitzpatrick TB. The validity and practicality of sun reactive skin types I through VI. Arch Dermatol. 1988;124:869–871. 27. Cil Y. Second-degree skin burn after intense pulsed light therapy with EMLA cream for hair removal. Int J Dermatol. 2009;48:206–207. 28. Radmanesh M, Azar-Beig M, Abtahian A, et al. Burning, paradoxical hypertrichosis, leukotrichia and folliculitis are four major complications of intense pulsed light hair removal therapy. J Dermatolog Treat. 2008;19:360–363. 29. Clayton JL, Edkins R, Cairns BA, et al. Incidence and management of adverse events after the use of laser therapies for the treatment of hypertrophic burn scars. Ann Plast Surg. 2013;70:500–505.
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Efficacy of Intense Pulsed Light for the Treatment of Burn Scar Dyschromias A Pilot Study to Assess Patient Satisfaction, Safety, and Willingness to Pay Charles Scott Hultman, MD, MBA, FACS, Jonathan S. Friedstat, MD, and Renee E. Edkins, NP, DNP Introduction: No treatment algorithms exist to reliably treat burn scar dyschromias. Intense pulsed light (IPL) has been used successfully to treat hyperpigmentation disorders, but has not been studied extensively in the treatment of burn scars. The purpose of this investigation was to assess clinical efficacy and patient satisfaction with IPL for the treatment of burn scar dyschromia. Methods: Patients with burn scar dyschromias were treated using the Lume 1 platform (Lumenis) to target pigmented lesions, using fluences between 10 and 22 joules/cm2 and filters ranging from 560 to 650 nm. At the conclusion of the study, providers assessed changes in burn scar dyschromia, whereas patients were queried regarding satisfaction and perceived efficacy, using a 1 to 5 Likert scale. The patients, who were not charged for the IPL treatment, were queried regarding willingness to pay. Results: Twenty patients (mean age, 35.4 years; mean total body surface area, 27.6%; mean composite Fitzpatrick score, 3.9) underwent IPL treatment of burn scar dyschromias, an average of 3.2 years after injury. Mean fluence was 15.4 J/cm2 (range, 10–22 J/cm2), and the most common filter used was 590 nm (range, 560–650 nm). Mean area treated was 90.7 cm2, with a range of 4 to 448 cm2. Complications included pain (4), hyperpigmentation (1), and blistering (2). Sixteen patients noted mild to moderate improvement, reporting a 4.5 for efficacy and a 4.4 for satisfaction. Regarding willingness to pay, patients would spend a mean of U.S. $7429 to completely remove their scars, but only a median of U.S. $350 to get the actual results that they received. Mean length of follow-up was 3.8 months, with a standard deviation of 2.2 months. Conclusions: Patients perceived IPL as an efficacious modality in the treatment of burn scar dyschromia, with a high level of satisfaction, despite the potential for morbidity. However, we are reluctant to recommend IPL for routine treatment of burn scar dyschromias, given only minimal improvement observed, potential for complications, and a willingness to pay that is lower than the cost of providing care. Key Words: burn scar, dyschromia, intense pulsed light (Ann Plast Surg 2015;74: S204–S208)
P
atients who develop scarring after burn injury are also at risk for disorders of pigmentation, otherwise known as dyschromias, due to damage of melanocytes and hair follicles in the various layers of the epidermis and dermis. In addition to potentially causing hypertrophic
Received November 1, 2014, and accepted for publication, after revision, December 16, 2014. From the Division of Plastic Surgery, University of North Carolina Health Care System, Chapel Hill, NC. Presented as a Member Paper at the 57th Annual Scientific Meeting of the SESPRS, June 8-12, 2014, Nassau, Bahamas SESPRS 2014 ANNUAL MEETING PAPER Conflict of interest and sources of funding: Ethel and James Valone Plastic Surgery Research Endowment. Reprints: Charles Scott Hultman, MD, MBA, FACS, Ethel and James Valone Distinguished Professor of Surgery, Chief and Program Director, Division of Plastic Surgery, Suite 7038, Burnett-Womack, CB 7195, University of North Carolina, Chapel Hill, NC 27599-7195. E-mail: [email protected]. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0148-7043/15/7404–S204 DOI: 10.1097/SAP.0000000000000447
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scars, keloids, contractures, and unstable wounds, thermal injury can lead to problems of abnormal texture, distortion of anatomic landmarks and borders, and hyperpigmentation and hypopigmentation.1–3 Although these latter conditions are not as functionally problematic as pathologic scar formation, the esthetic considerations can be quite distressing to the patient and may yield severe psychological sequelae. Options for improving burn scar dyschromia are limited. Although some modalities, such as topical steroids, hydroquinone, and retinoids, can reduce hyperpigmentation in the setting of nonthermal etiologies, no algorithms have been developed to treat burn patients with altered pigmentation. Over the past decade, advances in laserand light-based technologies have allowed providers to treat hypertrophic burn scars and achieve results not previously possible, through the delivery of energy that targets abnormal chromophores and induces remodeling of abnormal collagen in the dermis.4–12 Intense pulsed light (IPL) is an alternative platform that has documented efficacy in treating pigmentation disorders, such as melasma and solar elastosis, as well as hypertrichosis, chronic folliculitis, striae distensae, acne scarring, and photoaging.13–23 Few publications have explored the effect of IPL on hypertrophic scar formation, and only 2 reports have specifically addressed the use of IPL to treat burn scar abnormalities.24,25 The purpose of this investigation was to assess patient satisfaction, safety, and clinical efficacy of IPL for the treatment of burn scar dyschromia.
METHODS Study Design This investigation was a nonrandomized, noncontrolled, singlecohort, descriptive study, undertaken as a pilot project, to assess the safety and efficacy of IPL therapy for burn scars with mixed or hyperpigmentation. Patients presenting for consultation regarding management of burn scar dyschromia were invited to participate if they met the following criteria: were able to provide consent or have a parent provide consent; were at least 6 months after burn injury; had no open wounds in the area to be treated; were not presently using (or had in the previous 6 months used) topical lightening agents, retinoids, or corticosteroids; and had not undergone dermabrasion or chemical peels of the areas to be treated. Up to 2 sessions with the Lume One IPL platform (Lumenis, Santa Clara, CA) were provided free of charge, as an incentive to participate in the study.
Study Approval The University of North Carolina Biomedical Institutional Review Board approved this project as IRB Study 11-0946, under the title “Laser and/or Light Based Therapy for the Management of Hypertrophic, Hyperemic, or Dyschromic Burn Scars.”
Study Setting Patients were treated in an office-based setting, at the University of North Carolina. Referrals for treatment were received from the North Annals of Plastic Surgery • Volume 74, Supplement 4, June 2015
Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Annals of Plastic Surgery • Volume 74, Supplement 4, June 2015
IPL for Burn Scar Dyschromias
TABLE 1. Definitions of Fitzpatrick Skin Type Skin type
Burn Potential
Tan Potential
Skin Color
I II III IV V VI
Always Always easily Moderately Minimally Rarely Never
Never Minimally Uniformly Always Profusely Deeply pigmented
Pale white White Light brown Moderate brown Dark brown Black
Carolina Jaycee Burn Center, an accredited, verified burn center in the southeastern United States, which services a 6-state region (NC, SC, GA, WV, VA, TN).
Outcome Measures Participants were asked to assess the effect of IPL on their burn scar pigmentation, approximately 8 weeks after receiving treatment, using a 5-point Likert scale (5, significantly improved; 4, slightly improved; 3, no change; 2, slightly worse; 1, significantly worse). Additionally, participants were queried on their overall satisfaction with the treatment (5, very satisfied; 4, slightly satisfied; 3, neutral satisfaction; 2, slightly unsatisfied; 1, very unsatisfied). Patients were also asked if they would recommend such a procedure to another burn patient (yes/no) and if they would repeat the experience again (yes/no). Finally, we asked patients 2 questions about willingness to pay for the procedure: (1) how much money would you pay to completely remove your burn scars? And (2) how much money would you pay for your actual results?
RESULTS Twenty patients, with a mean age 35.4 years (range, 4–61; SD, 18.6) and a mean total body surface area burn of 27.6% (range, 1–90; SD, 29.0), underwent IPL treatment of burn scar dyschromia. Locations treated included face (n = 10), neck (n = 8), chest (n = 7), upper extremities (n = 12), lower extremities (n = 10), hands (n = 4), and abdomen (n = 1), with most patients having multiple anatomic sites treated. Patients had a mean composite Fitzpatrick score of 3.9, with a median and mode of 4 (range, 1–6). The cohort included 11 female and 9 male patients. Grading of Fitzpatrick score is listed in Table 1.26 The authors transcribed the composite scores of I to VI to 1 to 6. Regarding mechanism of burn injury, the distribution was as follows: flame (n = 9), scald (n = 5), contact (n = 3), electrical flash (n = 1), friction (n = 1), and ultrasound (n = 1). The IPL treatment occurred a mean of 3.2 years after injury (range, 1.0–15.2; median,
FIGURE 1. Improvement in burn scar hyperpigmentation, after 1 IPL session, in a patient with posttraumatic dyschromia of hand, wrist, and forearm. © 2015 Wolters Kluwer Health, Inc. All rights reserved.
FIGURE 2. A 24-year-old woman, after scald injury to her right arm, with minimal improvement in burn scar dyschromia, after 1 IPL session (preop on left, postop on right).
1.9; SD, 3.8). Mean length of follow-up was 3.8 months, with a standard deviation of 2.2 months and a range of 2 weeks to 6.8 months. Mean fluence used for the IPL treatment was 15.4 J/cm2 (range, 10–22 J/cm2), and the most common filter used was 590 nm (range, 560–650 nm). Mean area treated was 90.7 cm2, with a range of 4 to 448 cm2 and an SD of 118 cm2. Of the 20 patients, 17 had 1 session and 3 had 2 sessions. Seven patients experienced complications (35%), which include procedural and postprocedural pain (n = 4), postinflammatory hyperpigmentation (n = 1), mild blistering (n = 1), and moderate blistering (n = 1). Sixteen patients noted mild to significant improvement, reporting a 4.5 for efficacy, and a 4.4 for satisfaction. However, 1 patient who reported a 4 for efficacy, noted a 2 for satisfaction. Eleven patients noted that they would repeat the procedure if given the chance, and 13 patients would recommend the procedure to other burn patients with dyschromia. Regarding willingness to pay, patients indicated that they would spend a mean of U.S. $7429 (SD, U.S. $3756) to completely remove their scars (median, U.S. $10,000), but would spend only a mean of U.S. $1200 (SD, U.S. $2664) and to get the actual results that they received (median, U.S. $350). Economic utility of IPL, based on mean willingness to pay, would be U.S. $1200/ U.S. $7249 (or 17%). Based on median willingness to pay, economic utility drops to U.S. $350/U.S. $10,000 (or 4%). Sample patients are shown in Figures 1–4.
DISCUSSION In this pilot study of 20 patients undergoing IPL treatment for burn scar dyschromia, 16 (80%) reported mild to moderate improvement of hyperpigmentation, despite a complication/adverse event rate of 35%, which included procedural and postoperative pain, blistering, and 1 case of postinflammatory hyperpigmentation. One patient who failed to improve did have significant resolution of post-burn erythema with multiple, successive treatments, using a 595-nm PDL. Interestingly, although patients reported a 4.5 for efficacy and a 4.4 for satisfaction, using 1 to 5 Likert scale, their willingness to pay was fairly low. Even though patients would be willing to spend a mean of $7429 to completely remove their scars, they would only offer a median of $350 to get the actual results that they received, placing this procedure in a category of poor economic utility. This contrasts dramatically with previous “willingness to pay” data that we published, regarding use of lasers to treat hypertrophic burn scars, in which patients reported an economic utility of 84.8%.4 These patients were posed the scenario: if given a million dollars, how much money would you spend to completely remove your burn scars, and how much money would you spend to get your actual results. www.annalsplasticsurgery.com
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FIGURE 3. A 45-year-old woman, after grease burn to head, neck, and chest, after 2 IPL sessions, with moderate improvement of forehead but hyperpigmentation of chin and cheek (preop on left, postop on right). Superficial fractional CO2 laser resurfacing, in combination with a topical regimen of corticosteroid/hydroquinone/tretinoin, was required to improve this case of post-inflammatory hyperpigmentation (results not shown).
In terms of long-term patient satisfaction, patients who underwent PDL photothermolysis and fractional CO2 ablation of hypertrophic burn scars indicated that the treatments yielded moderate to definite improvement (mean of 4.78 on a 1–5 Likert scale), corresponding to a drop in Vancouver Scar Score from 10.43 to 5.16 (4 months after treatments) to 3.29 (25 months after treatments). Furthermore, they were
willing to part with $331,308 to eliminate their burn scars, and the patients would pay U.S. $2,220,356 to achieve the long-term results that they had, producing the economic utility of 84.8%. An objective provider assessment was not performed in the current study. However, the subjective interpretation of the authors was that IPL reduced hyperpigmentation in some cases, but these results were not predictable, consistent, or long-lasting. The most impressive case of improvement ironically came in a patient whose mixed forehead pigmentation became more confluent and less irregular, but who also developed hyperpigmentation in a separate site. She subsequently required superficial fractional CO2 ablative resurfacing to downregulate melanocyte production, in combination with a topical regimen of hydroquinone and tretinoin. Intense pulsed light is a relatively new technology, in which intense flashes of noncoherent light, distributed over a range of wavelengths from 500 nm to 1200 nm (depending on the cutoff filter used to block the lower spectrum of wavelengths), are directed at target chromophores in the skin.13 The result is somewhat nonspecific disruption of the targets, via transfer of energy and generation of heat; favorable targets include hair follicles and melanocytic lesions, because these chromophores are susceptible to the selected wavelengths, whereas other epidermal, dermal, and subdermal elements are relatively spared. Aesthetic indications include photoaging with solar elastosis, melasma, hypertrichosis, unwanted hair, chronic folliculitis, rosacea, striae distensae, and acne scarring.14–23 Over the past 10 years, management of hypertrophic burn scars has undergone a paradigm shift, moving from excision of the scar to modulation of existing scar, through the extensive remodeling can be effected by the use of new and developing laser-based technologies.1–12 Unlike IPL, lasers are coherent, monochromatic, and collimated, allowing
FIGURE 4. A 53-year-old man, who sustained a flame burn to face and chest, following one session of IPL, with minimal-to-no effect, and subsequent sessions with pulsed-dye laser, which did improve erythema (patient data not included in current study) (preoperative is on top, postoperative is on bottom). S206
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Annals of Plastic Surgery • Volume 74, Supplement 4, June 2015
the provider to precisely target abnormal chromophores in burned skin, which contains neovascularized scar, disorganized collagen, and pathologic fibroblasts and myofibroblasts. The current practice is to use pulsed-dye laser photothermolysis for immature, hypervascular, red scars (which may be painful and pruritic) and to use fractional CO2 laser ablation to decrease the thickness and improve the pliability of more mature, hypertrophic scars.4,11 Prediction and control of final pigmentation is quite difficult, especially in patients with increasing Fitzpatrick skin types. Current protocols include the use of topical corticosteroids, hydroquinone, and tretinoin, over the course of several months. Application of sunblock is critical during and after this period, as ultraviolet radiation stimulates melanocytes, and improvements in hyperpigmentation typically lessen over time, resulting in recurrent dyschromia. Intense pulsed light is an intriguing technology that could theoretically help in the management of post-burn hyperpigmentation. Despite fairly good evidence that IPL improves other aesthetic conditions, very little literature exists to support the use of IPL for burn scar dyschromia. In a prospective study from 2003, Ho et al24 reported that IPL resulted in a 50% clinical improvement in 15 of 19 Chinese patients, with a follow-up of 11 to 32 months. Two patients had no response, and 4 of the 19 patients, or 21.2%, developed complications of blistering or erythema. Since then, no other reports focusing on the IPL treatment of burn scar dyschromia have been published. The only other report that includes a significant number of burn patients, whose scars were treated by IPL, came from Erol et al25 in 2008. The authors studied the effect of IPL on height, erythema, hardness, and appearance, in 109 patients with surgical incisions (n = 55), traumatic lacerations and abrasions (n = 24), acne scars (n = 6), keloids (n = 5), and burns (n = 19), treated across an average of 8 sessions. Although they reported improvement in 92.5% of patients, in at least 1 measurable outcome, the authors did not specifically study dyschromia—the degree of pigment in the skin—nor did they perform a subgroup analysis of burn patients. Their use of IPL more closely approximates our use of PDL to treat hypertrophic, hyperemic scars. Despite relatively high patient satisfaction, with mild to moderate improvement in 80% of our patients, we do not recommend the routine use of IPL for the treatment of burn scar dyschromia. Some carefully selected patients may benefit from this modality, but managing patient expectations and avoiding patient complications are both critical. For a noninvasive, relatively safe laser/light platform, IPL can generate significant complications or adverse sequelae,27–29 perhaps due to the nonspecific nature of this energy source and the increased likelihood of producing collateral damage at a fluence required to downregulate burn scar melanocytes. Certainly, the use of IPL in patients with increased pigmentation, in the setting of a high Fitzpatrick skin type, should be done very cautiously. Other aspects of IPL which preclude us from recommending this therapy to treat burn scar hyperpigmentation include: (1) the variable efficacy observed in our limited patient population; (2) the need for multiple sessions to produce the response desired by the patient; (3) efficacy which appears to be similar to that of topical agents such as corticosteroids, hydroquinone, and tretinoin, 4) and probable recurrence of hyperpigmentation with ultraviolet light exposure, which is a well-documented limitation of IPL, when used for other cosmetic indications. The final consideration, which argues against the use of IPL for burn scar dyschromia, is economic. Because almost all insurance companies rightfully view burn scar dyschromia as cosmetic and do not reimburse for IPL, we do not believe that it is fair or responsible to charge burn patients the prices that the aesthetic market supports for other IPL treatments. Current charges, for a single session, range from U.S. $150 for a small area on the trunk, to U.S. $550 for both hands, to U.S. $1050 for the entire neck and face. The perceived value to our patients is certainly below what they would be willing to pay, given that they reported a “willingness to pay” of only U.S. $350, in a hypothetical model, in © 2015 Wolters Kluwer Health, Inc. All rights reserved.
IPL for Burn Scar Dyschromias
which they did not actually have to pay for the treatment. Furthermore, the actual price point at which the patient would assume responsibility for payment resides below the variable and overhead costs to provide that care. Because IPL has inconsistent efficacy, requires multiple sessions, yields results that are not lasting, is not superior to topical agents, and has the potential to produce real complications, we do not recommend the routine use of IPL for the treatment of burn scar dyschromia. ACKNOWLEDGMENT Informed consent has been received for publication of the figures in this article. REFERENCES 1. Tredgett EE, Levi B, Donelan MB. Biology and principles of scar management and burn reconstruction. Surg Clin N Am. 2014;94:793–815. 2. Cartotto R, Cicuto BJ, Kiwanuka HN, et al. Common postburn deformities and their management. Surg Clin N Am. 2014;94:817–837. 3. Friedstat JS, Hultman CS. Hypertrophic burn scar management: what does the evidence show? A systematic review of randomized controlled trials. Ann Plast Surg. 2014;72:S198–S201. 4. Hultman CS, Friedstat JS, Edkins RE, et al. Laser resurfacing and remodeling of hypertrophic burn scars: the results of a large, prospective, before-after cohort study, with long-term follow-up. Ann Surg. 2014;260:519–529; discussion 529–32. 5. Hultman CS, Edkins RE, Wu C, et al. Prospective, before-after cohort study to assess the efficacy of laser therapy on hypertrophic burn scars. Ann Plast Surg. 2013;70:521–526. 6. Taudorf EH, Danielsen PL, Paulsen IF, et al. Non-ablative fractional laser provides long-term improvement of mature burn scars-A randomized controlled trial with histological assessment. Lasers Surg Med. 2014. [Epub ahead of print]. 7. Khandelwal A, Yelvington M, Tang X, et al. Ablative fractional photothermolysis for the treatment of hypertrophic burn scars in adult and pediatric patients: a single surgeon's experience. J Burn Care Res. 2014;35:455–463. 8. Waibel JS, Wulkan AJ, Shumaker PR. Treatment of hypertrophic scars using laser and laser assisted corticosteroid delivery. Lasers Surg Med. 2013;45:135–140. 9. Ozog DM, Liu A, Chaffins ML, et al. Evaluation of clinical results, histological architecture, and collagen expression following treatment of mature burn scars with a fractional carbon dioxide laser. JAMA Dermatol. 2013;149:50–57. 10. Bailey JK, Burkes SA, Visscher MO, et al. Multimodal quantitative analysis of early pulsed-dye laser treatment of scars at a pediatric burn hospital. Dermatol Surg. 2012;38:1490–1496. 11. Anderson RR, Donelan MB, Hivnor C, et al. Laser treatment of traumatic scars with an emphasis on ablative fractional laser resurfacing: consensus report. JAMA Dermatol. 2014;150:187–193. 12. Donelan MB, Parrett BM, Sheridan RL. Pulsed dye laser therapy and z-plasty for facial burn scars: the alternative to excision. Ann Plast Surg. 2008;60:480–486. 13. Wat H, Wu DC, Rao J, et al. Application of intense pulsed light in the treatment of dermatologic disease: a systematic review. Dermatol Surg. 2014;40:359–377. 14. Shamsi Meymandi S, Rezazadeh A, Ekhlasi A. Studying intense pulsed light method along with corticosteroid injection in treating keloid scars. Iran Red Crescent Med J. 2014;16:e12464. 15. Vrijman C, van Drooge AM, Limpens J, et al. Laser and intense pulsed light therapy for the treatment of hypertrophic scars: a systematic review. Br J Dermatol. 2011;165:934–942. 16. Piccolo D, Di Marcantonio D, Crisman G, et al. Unconventional use of intense pulsed light. Biomed Res Int. 2014;2014:618206. 17. Ozdemir M, Engin B, Mevlitoğlu I. Treatment of facial port-wine stains with intense pulsed light: a prospective study. J Cosmet Dermatol. 2008;7:127–131. 18. Bellew SG, Weiss MA, Weiss RA. Comparison of intense pulsed light to 595-nm long-pulsed pulsed dye laser for treatment of hypertrophic surgical scars: a pilot study. J Drugs Dermatol. 2005;4:448–452. 19. Wang B, Wu Y, Luo YJ, et al. Combination of intense pulsed light and fractional CO(2) laser treatments for patients with acne with inflammatory and scarring lesions. Clin Exp Dermatol. 2013;38:344–351. 20. Trelles MA, Levy JL, Ghersetich I. Effects achieved on stretch marks by a nonfractional broadband infrared light system treatment. Aesthetic Plast Surg. 2008;32:523–530. 21. Hedelund L, Due E, Bjerring P, et al. Skin rejuvenation using intense pulsed light: a randomized controlled split-face trial with blinded response evaluation. Arch Dermatol. 2006;142:985–990.
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22. Hernández-Pérez E, Colombo-Charrier E, Valencia-Ibiett E. Intense pulsed light in the treatment of striae distensae. Dermatol Surg. 2002;28:1124–1130. 23. Cao Y, Huo R, Feng Y, et al. Effects of intense pulsed light on the biological properties and ultrastructure of skin dermal fibroblasts: potential roles in photoaging. Photomed Laser Surg. 2011;29:327–332. 24. Ho WS, Chan HH, Ying SY, et al. Prospective study on the treatment of postburn hyperpigmentation by intense pulsed light. Lasers Surg Med. 2003;32: 42–45. 25. Erol OO, Gurlek A, Agaoglu G, et al. Treatment of hypertrophic scars and keloids using intense pulsed light (IPL). Aesthetic Plast Surg. 2008;32:902–909.
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26. Fitzpatrick TB. The validity and practicality of sun reactive skin types I through VI. Arch Dermatol. 1988;124:869–871. 27. Cil Y. Second-degree skin burn after intense pulsed light therapy with EMLA cream for hair removal. Int J Dermatol. 2009;48:206–207. 28. Radmanesh M, Azar-Beig M, Abtahian A, et al. Burning, paradoxical hypertrichosis, leukotrichia and folliculitis are four major complications of intense pulsed light hair removal therapy. J Dermatolog Treat. 2008;19:360–363. 29. Clayton JL, Edkins R, Cairns BA, et al. Incidence and management of adverse events after the use of laser therapies for the treatment of hypertrophic burn scars. Ann Plast Surg. 2013;70:500–505.
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