Just Accepted by Journal of Cosmetic and Laser Therapy
The effectiveness of Excimer laser on vitiligo treatment in comparison with combination therapy of Excimer laser and tacrolimus in Iranian population J Cosmet Laser Ther Downloaded from informahealthcare.com by Memorial University of Newfoundland on 08/03/14 For personal use only.
Marzieh Matin , Sahar Latifi, Nasrin Zoufan, Davood Koushki, Seyedeh Adeleh Mirjafari Daryasari, Fereshteh Rahdari 10.3109/14764172.2014.946049 Abstract Objectives: Usage of 308-nm excimer laser (EL) is an effective treatment in vitiligo. As genetic predispositions along with type of skin and sun exposure rate are known factor influencing the treatment outcomes we tried to evaluate treatment results of using 308nm-excimer laser alone in comparison with combined therapy of EL and topical tarcolimus in Iranian patients with vitiligo. Methods: We reviewed medical files of 150 patients with vitiligo who were referred to Behsima laser center from April 2012 to April 2013. Seventy five Patients who received combined therapy of 308nm EL and topical tacrolimus three times a week entered the study. Seventy five controls with matched characteristics who received only EL were also selected. Repigmentaion amount was estimated by an expert dermatologist and was classified in 5 ranks. Results: In case group 33.3%(n:25) revealed 50-75% repigmentation and 49.3%(n:37) had more than 75% response to therapy whereas in patients in control group 29.3%( n:22) showed no repigmentation and only 8%(n:6) demonstrated more than 75% repigmentation response. The higher efficiency of combination therapy on repigmentation was statistically significant (P: 0.006). Conclusion: Our study shows that Iranian patients with vitiligo who received combined treatment course with 308-nm EL and tacrolimus 0.1% experienced significantly higher level of repigmentation in comparison with laser therapy alone.
© 2014 Informa UK, Ltd. This provisional PDF corresponds to the article as it appeared upon acceptance. Fully formatted PDF and full text (HTML) versions will be made available soon. DISCLAIMER: The ideas and opinions expressed in the journal’s Just Accepted articles do not necessarily reflect those of Informa Healthcare (the Publisher), the Editors or the journal. The Publisher does not assume any responsibility for any injury and/or damage to persons or property arising from or related to any use of the material contained in these articles. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosages, the method and duration of administration, and contraindications. It is the responsibility of the treating physician or other health care professional, relying on his or her independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Just Accepted articles have undergone full scientific review but none of the additional editorial preparation, such as copyediting, typesetting, and proofreading, as have articles published in the traditional manner. There may, therefore, be errors in Just Accepted articles that will be corrected in the final print and final online version of the article. Any use of the Just Accepted articles is subject to the express understanding that the papers have not yet gone through the full quality control process prior to publication.
The effectiveness of Excimer laser on vitiligo treatment in comparison with combination therapy of Excimer laser and tacrolimus in Iranian population Marzieh Matin 1, Sahar Latifi1, Nasrin Zoufan2, Davood Koushki3, Seyedeh Adeleh Mirjafari
Brain and Spinal Injury Research Center (BASIR), Tehran University of Medical Sciences,
Tehran, Iran, 2Behsima Laser Center, Islamic Azad University-Tehran Medical Branch , Tehran, Iran, Tehran, Iran, 3Iran University of Medical Sciences, Tehran, Iran.
Correspondence: Sahar Latifi, Brain and Spinal Injury Research Center (BASIR), Tehran University of Medical Sciences, Block 6, shahrak daneshgah, 12 km of Lashgari highway, Tehran, Iran. Tel: +982144908768. Tel: +989125353259. Email: [email protected]. Alternative Email: s-
Short Title: Laser therapy in vitiligo Abstract
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[email protected]
Objectives: Usage of 308-nm excimer laser (EL) is an effective treatment in vitiligo. As genetic
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predispositions along with type of skin and sun exposure rate are known factor influencing the treatment outcomes we tried to evaluate treatment results of using 308nm-excimer laser alone in comparison with combined therapy of EL and topical tarcolimus in Iranian patients with vitiligo.
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Methods: We reviewed medical files of 150 patients with vitiligo who were referred to Behsima laser center from April 2012 to April 2013. Seventy five Patients who received combined therapy of 308nm EL and topical tacrolimus three times a week entered the study. Seventy five controls with matched characteristics who received only EL were also selected. Repigmentaion
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1
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Daryasari1, Fereshteh Rahdari1
amount was estimated by an expert dermatologist and was classified in 5 ranks. Results: In case group 33.3%(n:25) revealed 50-75% repigmentation and 49.3%(n:37) had more than 75% response to therapy whereas in patients in control group 29.3%( n:22) showed no repigmentation and only 8%(n:6) demonstrated more than 75% repigmentation response. The higher efficiency
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of combination therapy on repigmentation was statistically significant (P: 0.006). Conclusion: Our study shows that Iranian patients with vitiligo who received combined treatment course with 308-nm EL and tacrolimus 0.1% experienced significantly higher level of repigmentation in
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comparison with laser therapy alone.
Introduction
Vitiligo is a form of skin disease manifesting with skin depigmentation due to dysfunction of melanocytes. It is characterized by depigmented milky white patches and macules (1) .Etiologies are not well-known but previously autoimmune, genetic, neural and viral causes are proposed
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(2). The worldwide incidence is reported less that 1 % (3) and the comparison between populations have revealed that people with fair skin, including individuals with albinism are significantly more susceptible to skin damages due to sun exposure (4) that can be a trigger to
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vitiligo development. Genetic bases of people predisposition to vitiligo have been discussed recently (5, 6). This fact insists that different populations with different genetic characteristics can have various responses to vitiligo treatment. Depigmented patches in vitiligo are described to
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occur mostly in extrimities (7, 8). There are four types of therapy proposed for vitiligo treatment up to now: UVB phototherapy, PUVA phototherapy (9), transplanting melanocytes and skin camouflage. By using phototherapy which is a stimulator of migration in adjacent melanocytes to underlying hair follicles, less than 20% of patients experience full repigmentation whereas partial
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Key words: vitiligo, laser therapy, repigmentation
repigmentation have been reported in 30% to 40% (10-12).. Monochromatic excimer light (MEL, 308 nm) utilizing the xenon-chloride (XeCl) gas combination is the newest phototherapy technology which is proposed recently for vitiligo management. Excimer device uses a rare (nobel) gas and a halogen gas to emit an excess energy in which the spectrum is dependent on
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the gas utilized (13). Balta´s et al. reported the first case of successful use of the excimer laser for the treatment of vitiligo in 2001(14), since then Excimer laser is used vastly to manage vitiligo .The clinical efficiency of MEL is superior to UVB due to more induction of T-cell apoptosis
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(15). MEL also up regulates Endothelin-1 release which promotes melanocytes function (16, 17).
and 0.1% tacrolimus ointment in comparison with 308-nm excimer laser alone (18-21) but this effect was not yet evaluated up to now in Iranian population. Our purpose was to compare the efficiency of 308-nm excimer laser administration with combined therapy of tacrolimus ointment 0.1% and 308-nm excimer laser on Iranian patients with vitiligo. By considering the fact that
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genetic factors which have been described before are proposed as suspicious factors influencing the prognosis and treatment outcomes of vitiligo management, this study is the first study
Material and methods Study design
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evaluating vitiligo treatment outcomes in Iran.
This study was designed retrograde observational study. The study was approved by the research
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ethics committee of Tehran Azad University of Medical Sciences. Data were collected within one month (July 2013) and medical files of patients who received EL or ELT from April 2012 to April 2013 were reviewed. Participants
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Studies have demonstrated the superior effect of combined therapy with 308-nm excimer laser
Medical files of 150 patients who have been undergone treatment in Behsima laser center were reviewed. Case group consisted of 75 patients who received 30 sessions of 308-nm Excimer laser combined with tacrolimus ointment 0.1% topically (ELT) administered once per day. Control group consisted of 75 patients with total session of 30 treatment courses with 308-nm Excimer
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(EL). In both groups EL was implemented three times a week. Inclusion criteria were: 1. Patinets with generalized vitiligo (multiple lesions at different body sites). 2. Stable vitiligo patches in patients with no previous treatment or those that had stopped their previous treatment for at least
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8 weeks before receiving EL or ELT in Behsima laser center. Exclusion criteria were active
within the last 8 weeks before receiving laser sessions. The two groups were matched in demographic features, type and location of vitiligo and the time interval since appearance of vitiligo patches. Patient’s demographic data including age, sex, weight, height, body mass index and time since disease were also matched. By considering the fact that type of disease influence
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on treatment outcome, we only entered those patients with non-segmental vitiligo vulgaris into the investigation. All cases and controls had generalized vitiligo which is characterized by wide and randomly distributed areas of depigmentation.
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Previous investigations have revealed the safety of implementation of excimer laser with or without immunosuppressive agents in vitiligo in Asians (22). In this investigation, as we reviewed medical files our power was restricted in detecting laser-therapy induced
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complications. The assessment of safety of these procedures was limited to evaluation of reported complications in medical files. In this regard no significant complication associated with implementation of EL or ELT was detected. Pigmentaion assessment
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vitiligo or the use of immunosuppressive agents (whether systemically or topical application)
As involvement of hairless areas and dorsal root of extremities are accompanied with poorer response to treatment, we tried to assimilate involvement locations by selecting patients with similar vitiligo areas in both case and control groups. All patients were examined by expert dermatologist to confirm the diagnosis of vitiligo and response to treatment was also assessed by
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one expert to omit the bias effect of lesions interpretation. This assessment was based on Vitiligo Area Scoring Index (VASI) which was introduced by Hamzavi et al.(23). According to this scale VASI is assessed by multiplying ‘Hand Units’ in ‘Residual Depigmentation’. Repigmentation
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response rate was reported by one similar expert dermatologist and was described as: no
Statistical analysis
All data were analyzed with SPSS software version 18 (SPSS Inc., Chicago IL, USA). We used descriptive statistics to report frequency of patients in each rank of ‘response to treatment’. Pearson chi-square test (t-test) was used to identify the relationship between treatment course
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and improvement degree. The effect of age and disease duration of repigmentation was evaluated by comparison of means in each categorized group of repigmentation by one-way analysis of
Results
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variances (ANOVA)
One hundred and fifty patients were selected to enter the study into 2 groups of EL (control group) and ELT. Demographic features between these two groups were matched. Mean age in
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control group (patients receiving only 308-nm Excimer laser therapy) was 45.03±14.33 years and in case group (patients receiving combined therapy with 308-nm Excimer laser and tacrolimus ointment 0.1%) was 47.87± 14.58 years. Control group consisted of 54.7% males and 45.3% females and case group included 44.0% males and 56.0% females which shows the matched sex
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response, less than 25% response, 25-50%, 50-75% and more than 75% response.
distribution between these two groups. Age distribution in both groups were matched and showed no statistically significant difference. In patients in control group 29.3 % (n: 22) showed no repigmentation, 36 % (n: 27) had less than 25% repigmentation, 17.3% (n: 13) revealed 2550%, 9.3% (n: 7) showed 50-75% and only 8 % (n: 6) demonstrated more than 75%
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repigmentation response. This data shows that most patients receiving only 308-nm Excimer laser as vitiligo treatment experience lesser than 25% repigmentation. In case group 17.3% (n: 13) of patients showed 25-50% repigmentation, 33.3% (n: 25) revealed 50-75 and 49.3% (n: 37)
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had more than 75% repigmentation as a response to therapy (Figure 1). No patients in ELT group
most patients with vitiligo receiving combined therapy of 308-nm Excimer laser and tacrolimus ointment 0.1% experience more than 75% improvement.
We also tried to evaluate sex effect on repigmentation response. Among patients with no response to therapy 63.6% (n: 14) were male and 36.4% (n: 8) were female. Patient with less
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than 25% improvement in skin pigmentation consisted of 37% (n: 10) male and 63% (n: 17) female. In patients showing 25-50% repigmentation in both groups 57.7 % (n: 15) were male and 42.3% (n: 11) were female (Table 1). No significant relationship could be detected between sex
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and treatment response level. All patient with no response to treatment course belonged to control group and 88% of patients with more than 75% repigmentation belonged to ELT group. The higher efficiency of combination therapy on vitiligo repigmentation was statistically
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significant (P: 0.006) (Figure 1).
No significant association between age and repigmentation rate was detected. Mean disease duration was 24.51±24.92 months in patients receiving EL and 23.79±21.73 months in patients receiving ELT which shows the matched time duration of disease between these two groups. No
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were detected to show ‘no repigmentation’ or ‘less than 25%’. These results demonstrate that
significant correlation between disease duration (time interval since onset of vitiligo patches appearance) and repigmentation rate in both groups could be detected. Discussion
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Vitiligo is a skin condition with manifestation of white patches and melanocyte dysfunction. Although many treatments have been proposed for vitiligo but outcomes were disappointing up to now. Recent studies suggest combinations of existing therapies. Lee et al. have demonstrated
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topical tacrolimus as an effective agent for vitiligo treatment due to its melanocyte migration
is more effective in vitiligo management than other types of phototherapy and its efficiency can also be improved in combination with corticosteroids, Pimecrolimus and tacrolimus (24). A clinical trial in 2012 revealed that unsatisfactory repigmentation in vitiligo was achieved when tacrolimus was used alone (25) while Kawalek et al. illustrated superior outcomes of
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combination therapy of excimer laser and tacrolimus than only usage of excimer laser as well (19). Our study shows that patients with vitiligo who received combined treatment course with 308-nm excimer laser and tacrolimus 0.1% experienced significantly higher level of
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repigmentation in comparison with individuals who only underwent laser therapy (P: 0.006). Our results are in line with previous published reports. Factors which were proposed to be vitiligo triggers included sun exposure, skin type and color and higher incidence of vitiligo was observed
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in people with albinism and fair skin (4). Skin damaged due to sun exposure is another known factor. As the skin type of Iranian patients and degree of sun exposure is different from other nations, this investigation tried to evaluate treatment outcomes in Iranian patients with vitiligo. These data demonstrate that treatment results of vitiligo management are more satisfactory when
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stimulatory action or TNF-α inhibitory effect (8). Alhowaish et al. illustrated that Excimer laser
combined therapy of excimer laser and tacrolimus is used rather than applying only laser therapy in Iranian population. This effect is significant despite from race, sun exposure duration and other factors which differ between populations and may influence the results of vitiligo treatment. To our knowledge this is the first study evaluating the effect of combined therapy with
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excimer laser and tacrolimus in Iranian patients with vitiligo. We recommend here to dermatologist who are working in lase centers in Iran to use combined therapy of excimer laser and tacrolimus rather than excimer laser alone. This paper can be used as a citation for those
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dermatologists who apply treatment methods in patients with vitiligo in Iran.
Although this study gives clinician a suitable evidence to cite for running laser treatments by using a matched control group but it is essential that findings of this retrograde observational study be confirmed in clinical trials in Iran. However it is considerable that as this study was based on reviews of medical files our power in determining laser therapy induced complications
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were limited to records in these files. While our retrograde observational study detected no specific complication associated with implemented treatments, declaring safety of these procedures in Iranian population may need long term follow ups investigations. Sun exposure
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duration was another factor that was not measured in this study however all included patients were inhabitants of Tehran and had comparable outdoor activity which led to relative homogenous population.
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Disclosure of Interest
We declare that there is no conflict of interest in any terms and conditions related to this paper. Disclosure
There is nothing to declare as competing interest for any of the authors including the
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Study Limitation
corresponding author. Acknowledgement
This investigation was supported by Islamic Azad University-Tehran Medical Branch, Tehran, Iran. We like to thank all staff that helped us in data collection in Behsima laser center.
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Authorship All the authors have contributed enough towards this publication to justify authorship criteria
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Copyright
Dermatology if it is accepted for publication. We warrant that this paper is original and has not been in part or in whole simultaneously submitted to or published in another journal.
Conflict of interest
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There is no conflict of interest of any of the authors with the results of this study.
Ethics committee / Institutional review board’s permission
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We also declare that the study was assessed and approved by the institutional ethics committee / institutional review board.
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Permission
Copy of permission(s), if any, to reproduce published material is enclosed.
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We transfer all copyright ownership of the enclosed manuscript to the Indian Journal of
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Balta´s E, Nagy P, Bonis B, Novák Z, Ignácz F, Szabó G,et al. Repigmentation of
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localized vitiligo with the xenon chloride laser. Br J Dermatol 2001;144:1266–7.
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1995;30(1):71-6.
Ozawa M, Ferenczi K, Kikuchi T, Cardinale I, Austin LM, Coven TR, et al. 312-
nanometer ultraviolet B light (narrow-band UVB) induces apoptosis of T cells within psoriaticlesions. J Exp Med. 1999;189(4);711-8.
Noborio R, Kobayashi K, Shintani Y, Morita A. Comparison of the efficacy of
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calcipotriol and maxacalcitol in combination with narrow-band ultraviolet B therapy for the treatment of psoriasis vulgaris. Photodermatol Photoimmunol Photomed 2006;22:262–4 (2006).
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Passeron T, Ostovari N, Zakaria W, Fontas E, Larrouy JC, Lacour JP et al. Topical
tacrolimus and the 308-nm excimer laser: a synergistic combination for the treatment of vitiligo. Arch Dermatol 2004;140(9):1065-9. 19.
Kawalek AZ, Spencer JM, Phelps RG. Combined excimer laser and topical tacrolimus
for the treatment of vitiligo: a pilot study. Dermatol Surg. 2004;30(2 pt 1):130-5. 11
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Passeron T, Ortonne JP. The 308 nm excimer laser in dermatology. Presse Med
2005;34(4):301-9. 21.
Radakovic S, Breier-Maly J, Konschitzky R. Response of vitiligo to oncevs. twice-daily
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Al-Otaibi SR, Zadeh VB, Al-Abdulrazzaq AH, Tarrab SM, Al-Owaidi HA, Mahrous R,
et al. Using a 308-nm excimer laser to treat vitiligo in Asians. Acta Dermatovenerol Alp Panonica Adriat. 2009;18(1):13-9. 23.
Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of
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narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004:140(6):677-83. 24.
Alhowaish AK, Dietrich N, Onder M, Fritz K. Effectiveness of a 308-nm excimer laser in
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treatment of vitiligo: a review. Lasers Med Sci. 2013;28(3):1035-41. Kathuria S, Khaitan BK, Ramam M, Sharma VK. Segmental vitiligo: a randomized
controlled trial to evaluate efficacy and safety of 0.1% tacrolimus ointment vs 0.05% fluticasone
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propionate cream. Indian J Dermatol Venereol Leprol. 2012;78(1):68-73.
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Dermatol Venereol 2009;23(8): 951-3.
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topical tacrolimus: a controlled prospective, randomized, observer-blined trial, J Eur Acad
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Figure 1: Outcomes of repigmentation in patients with vitiligo who underwent excimer or
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excimer+ tropical tacrolimus treatment
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Figure legends:
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Male
Female
Association
No repigmentation
63.6% (n: 14)
36.4% (n: 8)
NS
Less than 25%
37.0% (n: 10)
25-50%
57.7% (n: 15)
50-75%
53.1% (n: 17)
More than 75%
41.9% (n: 18)
63.0% (n: 17)
NS
42.3% (n: 11)
NS
46.9% (n: 15)
NS
58.1% (n:25)
NS
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NS: No significant relationship
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Repigmentation
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Table 1: Sex effect on repigmentation rate in both groups of EL and ELT
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39.77
Less than 25% Repigmentation
44.15
25%-50% Repigmentation
45.23
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No Repigmentation
50%-75% Repigmentation
49.88
More than 75% Repigmentation
49.49
Age effect significance
No Significant correlation
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The age effect was evaluated by comparison of means (mean age in each categorized group of repigmentation) by one-way analysis of variance (ANOVA)
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Table 2: Age effect on vitiligo treatment outcomes in both groups of EL and ELT Mean Age(years)
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The effectiveness of Excimer laser on vitiligo treatment in comparison with combination therapy of Excimer laser and tacrolimus in Iranian population J Cosmet Laser Ther Downloaded from informahealthcare.com by Memorial University of Newfoundland on 08/03/14 For personal use only.
Marzieh Matin , Sahar Latifi, Nasrin Zoufan, Davood Koushki, Seyedeh Adeleh Mirjafari Daryasari, Fereshteh Rahdari 10.3109/14764172.2014.946049 Abstract Objectives: Usage of 308-nm excimer laser (EL) is an effective treatment in vitiligo. As genetic predispositions along with type of skin and sun exposure rate are known factor influencing the treatment outcomes we tried to evaluate treatment results of using 308nm-excimer laser alone in comparison with combined therapy of EL and topical tarcolimus in Iranian patients with vitiligo. Methods: We reviewed medical files of 150 patients with vitiligo who were referred to Behsima laser center from April 2012 to April 2013. Seventy five Patients who received combined therapy of 308nm EL and topical tacrolimus three times a week entered the study. Seventy five controls with matched characteristics who received only EL were also selected. Repigmentaion amount was estimated by an expert dermatologist and was classified in 5 ranks. Results: In case group 33.3%(n:25) revealed 50-75% repigmentation and 49.3%(n:37) had more than 75% response to therapy whereas in patients in control group 29.3%( n:22) showed no repigmentation and only 8%(n:6) demonstrated more than 75% repigmentation response. The higher efficiency of combination therapy on repigmentation was statistically significant (P: 0.006). Conclusion: Our study shows that Iranian patients with vitiligo who received combined treatment course with 308-nm EL and tacrolimus 0.1% experienced significantly higher level of repigmentation in comparison with laser therapy alone.
© 2014 Informa UK, Ltd. This provisional PDF corresponds to the article as it appeared upon acceptance. Fully formatted PDF and full text (HTML) versions will be made available soon. DISCLAIMER: The ideas and opinions expressed in the journal’s Just Accepted articles do not necessarily reflect those of Informa Healthcare (the Publisher), the Editors or the journal. The Publisher does not assume any responsibility for any injury and/or damage to persons or property arising from or related to any use of the material contained in these articles. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosages, the method and duration of administration, and contraindications. It is the responsibility of the treating physician or other health care professional, relying on his or her independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Just Accepted articles have undergone full scientific review but none of the additional editorial preparation, such as copyediting, typesetting, and proofreading, as have articles published in the traditional manner. There may, therefore, be errors in Just Accepted articles that will be corrected in the final print and final online version of the article. Any use of the Just Accepted articles is subject to the express understanding that the papers have not yet gone through the full quality control process prior to publication.
The effectiveness of Excimer laser on vitiligo treatment in comparison with combination therapy of Excimer laser and tacrolimus in Iranian population Marzieh Matin 1, Sahar Latifi1, Nasrin Zoufan2, Davood Koushki3, Seyedeh Adeleh Mirjafari
Brain and Spinal Injury Research Center (BASIR), Tehran University of Medical Sciences,
Tehran, Iran, 2Behsima Laser Center, Islamic Azad University-Tehran Medical Branch , Tehran, Iran, Tehran, Iran, 3Iran University of Medical Sciences, Tehran, Iran.
Correspondence: Sahar Latifi, Brain and Spinal Injury Research Center (BASIR), Tehran University of Medical Sciences, Block 6, shahrak daneshgah, 12 km of Lashgari highway, Tehran, Iran. Tel: +982144908768. Tel: +989125353259. Email: [email protected]. Alternative Email: s-
Short Title: Laser therapy in vitiligo Abstract
CE
[email protected]
Objectives: Usage of 308-nm excimer laser (EL) is an effective treatment in vitiligo. As genetic
AC
predispositions along with type of skin and sun exposure rate are known factor influencing the treatment outcomes we tried to evaluate treatment results of using 308nm-excimer laser alone in comparison with combined therapy of EL and topical tarcolimus in Iranian patients with vitiligo.
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Methods: We reviewed medical files of 150 patients with vitiligo who were referred to Behsima laser center from April 2012 to April 2013. Seventy five Patients who received combined therapy of 308nm EL and topical tacrolimus three times a week entered the study. Seventy five controls with matched characteristics who received only EL were also selected. Repigmentaion
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1
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Daryasari1, Fereshteh Rahdari1
amount was estimated by an expert dermatologist and was classified in 5 ranks. Results: In case group 33.3%(n:25) revealed 50-75% repigmentation and 49.3%(n:37) had more than 75% response to therapy whereas in patients in control group 29.3%( n:22) showed no repigmentation and only 8%(n:6) demonstrated more than 75% repigmentation response. The higher efficiency
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of combination therapy on repigmentation was statistically significant (P: 0.006). Conclusion: Our study shows that Iranian patients with vitiligo who received combined treatment course with 308-nm EL and tacrolimus 0.1% experienced significantly higher level of repigmentation in
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comparison with laser therapy alone.
Introduction
Vitiligo is a form of skin disease manifesting with skin depigmentation due to dysfunction of melanocytes. It is characterized by depigmented milky white patches and macules (1) .Etiologies are not well-known but previously autoimmune, genetic, neural and viral causes are proposed
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(2). The worldwide incidence is reported less that 1 % (3) and the comparison between populations have revealed that people with fair skin, including individuals with albinism are significantly more susceptible to skin damages due to sun exposure (4) that can be a trigger to
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vitiligo development. Genetic bases of people predisposition to vitiligo have been discussed recently (5, 6). This fact insists that different populations with different genetic characteristics can have various responses to vitiligo treatment. Depigmented patches in vitiligo are described to
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occur mostly in extrimities (7, 8). There are four types of therapy proposed for vitiligo treatment up to now: UVB phototherapy, PUVA phototherapy (9), transplanting melanocytes and skin camouflage. By using phototherapy which is a stimulator of migration in adjacent melanocytes to underlying hair follicles, less than 20% of patients experience full repigmentation whereas partial
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Key words: vitiligo, laser therapy, repigmentation
repigmentation have been reported in 30% to 40% (10-12).. Monochromatic excimer light (MEL, 308 nm) utilizing the xenon-chloride (XeCl) gas combination is the newest phototherapy technology which is proposed recently for vitiligo management. Excimer device uses a rare (nobel) gas and a halogen gas to emit an excess energy in which the spectrum is dependent on
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the gas utilized (13). Balta´s et al. reported the first case of successful use of the excimer laser for the treatment of vitiligo in 2001(14), since then Excimer laser is used vastly to manage vitiligo .The clinical efficiency of MEL is superior to UVB due to more induction of T-cell apoptosis
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(15). MEL also up regulates Endothelin-1 release which promotes melanocytes function (16, 17).
and 0.1% tacrolimus ointment in comparison with 308-nm excimer laser alone (18-21) but this effect was not yet evaluated up to now in Iranian population. Our purpose was to compare the efficiency of 308-nm excimer laser administration with combined therapy of tacrolimus ointment 0.1% and 308-nm excimer laser on Iranian patients with vitiligo. By considering the fact that
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genetic factors which have been described before are proposed as suspicious factors influencing the prognosis and treatment outcomes of vitiligo management, this study is the first study
Material and methods Study design
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evaluating vitiligo treatment outcomes in Iran.
This study was designed retrograde observational study. The study was approved by the research
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ethics committee of Tehran Azad University of Medical Sciences. Data were collected within one month (July 2013) and medical files of patients who received EL or ELT from April 2012 to April 2013 were reviewed. Participants
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Studies have demonstrated the superior effect of combined therapy with 308-nm excimer laser
Medical files of 150 patients who have been undergone treatment in Behsima laser center were reviewed. Case group consisted of 75 patients who received 30 sessions of 308-nm Excimer laser combined with tacrolimus ointment 0.1% topically (ELT) administered once per day. Control group consisted of 75 patients with total session of 30 treatment courses with 308-nm Excimer
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(EL). In both groups EL was implemented three times a week. Inclusion criteria were: 1. Patinets with generalized vitiligo (multiple lesions at different body sites). 2. Stable vitiligo patches in patients with no previous treatment or those that had stopped their previous treatment for at least
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8 weeks before receiving EL or ELT in Behsima laser center. Exclusion criteria were active
within the last 8 weeks before receiving laser sessions. The two groups were matched in demographic features, type and location of vitiligo and the time interval since appearance of vitiligo patches. Patient’s demographic data including age, sex, weight, height, body mass index and time since disease were also matched. By considering the fact that type of disease influence
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on treatment outcome, we only entered those patients with non-segmental vitiligo vulgaris into the investigation. All cases and controls had generalized vitiligo which is characterized by wide and randomly distributed areas of depigmentation.
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Previous investigations have revealed the safety of implementation of excimer laser with or without immunosuppressive agents in vitiligo in Asians (22). In this investigation, as we reviewed medical files our power was restricted in detecting laser-therapy induced
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complications. The assessment of safety of these procedures was limited to evaluation of reported complications in medical files. In this regard no significant complication associated with implementation of EL or ELT was detected. Pigmentaion assessment
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vitiligo or the use of immunosuppressive agents (whether systemically or topical application)
As involvement of hairless areas and dorsal root of extremities are accompanied with poorer response to treatment, we tried to assimilate involvement locations by selecting patients with similar vitiligo areas in both case and control groups. All patients were examined by expert dermatologist to confirm the diagnosis of vitiligo and response to treatment was also assessed by
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one expert to omit the bias effect of lesions interpretation. This assessment was based on Vitiligo Area Scoring Index (VASI) which was introduced by Hamzavi et al.(23). According to this scale VASI is assessed by multiplying ‘Hand Units’ in ‘Residual Depigmentation’. Repigmentation
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response rate was reported by one similar expert dermatologist and was described as: no
Statistical analysis
All data were analyzed with SPSS software version 18 (SPSS Inc., Chicago IL, USA). We used descriptive statistics to report frequency of patients in each rank of ‘response to treatment’. Pearson chi-square test (t-test) was used to identify the relationship between treatment course
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and improvement degree. The effect of age and disease duration of repigmentation was evaluated by comparison of means in each categorized group of repigmentation by one-way analysis of
Results
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variances (ANOVA)
One hundred and fifty patients were selected to enter the study into 2 groups of EL (control group) and ELT. Demographic features between these two groups were matched. Mean age in
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control group (patients receiving only 308-nm Excimer laser therapy) was 45.03±14.33 years and in case group (patients receiving combined therapy with 308-nm Excimer laser and tacrolimus ointment 0.1%) was 47.87± 14.58 years. Control group consisted of 54.7% males and 45.3% females and case group included 44.0% males and 56.0% females which shows the matched sex
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response, less than 25% response, 25-50%, 50-75% and more than 75% response.
distribution between these two groups. Age distribution in both groups were matched and showed no statistically significant difference. In patients in control group 29.3 % (n: 22) showed no repigmentation, 36 % (n: 27) had less than 25% repigmentation, 17.3% (n: 13) revealed 2550%, 9.3% (n: 7) showed 50-75% and only 8 % (n: 6) demonstrated more than 75%
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repigmentation response. This data shows that most patients receiving only 308-nm Excimer laser as vitiligo treatment experience lesser than 25% repigmentation. In case group 17.3% (n: 13) of patients showed 25-50% repigmentation, 33.3% (n: 25) revealed 50-75 and 49.3% (n: 37)
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had more than 75% repigmentation as a response to therapy (Figure 1). No patients in ELT group
most patients with vitiligo receiving combined therapy of 308-nm Excimer laser and tacrolimus ointment 0.1% experience more than 75% improvement.
We also tried to evaluate sex effect on repigmentation response. Among patients with no response to therapy 63.6% (n: 14) were male and 36.4% (n: 8) were female. Patient with less
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than 25% improvement in skin pigmentation consisted of 37% (n: 10) male and 63% (n: 17) female. In patients showing 25-50% repigmentation in both groups 57.7 % (n: 15) were male and 42.3% (n: 11) were female (Table 1). No significant relationship could be detected between sex
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and treatment response level. All patient with no response to treatment course belonged to control group and 88% of patients with more than 75% repigmentation belonged to ELT group. The higher efficiency of combination therapy on vitiligo repigmentation was statistically
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significant (P: 0.006) (Figure 1).
No significant association between age and repigmentation rate was detected. Mean disease duration was 24.51±24.92 months in patients receiving EL and 23.79±21.73 months in patients receiving ELT which shows the matched time duration of disease between these two groups. No
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were detected to show ‘no repigmentation’ or ‘less than 25%’. These results demonstrate that
significant correlation between disease duration (time interval since onset of vitiligo patches appearance) and repigmentation rate in both groups could be detected. Discussion
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Vitiligo is a skin condition with manifestation of white patches and melanocyte dysfunction. Although many treatments have been proposed for vitiligo but outcomes were disappointing up to now. Recent studies suggest combinations of existing therapies. Lee et al. have demonstrated
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topical tacrolimus as an effective agent for vitiligo treatment due to its melanocyte migration
is more effective in vitiligo management than other types of phototherapy and its efficiency can also be improved in combination with corticosteroids, Pimecrolimus and tacrolimus (24). A clinical trial in 2012 revealed that unsatisfactory repigmentation in vitiligo was achieved when tacrolimus was used alone (25) while Kawalek et al. illustrated superior outcomes of
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combination therapy of excimer laser and tacrolimus than only usage of excimer laser as well (19). Our study shows that patients with vitiligo who received combined treatment course with 308-nm excimer laser and tacrolimus 0.1% experienced significantly higher level of
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repigmentation in comparison with individuals who only underwent laser therapy (P: 0.006). Our results are in line with previous published reports. Factors which were proposed to be vitiligo triggers included sun exposure, skin type and color and higher incidence of vitiligo was observed
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in people with albinism and fair skin (4). Skin damaged due to sun exposure is another known factor. As the skin type of Iranian patients and degree of sun exposure is different from other nations, this investigation tried to evaluate treatment outcomes in Iranian patients with vitiligo. These data demonstrate that treatment results of vitiligo management are more satisfactory when
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stimulatory action or TNF-α inhibitory effect (8). Alhowaish et al. illustrated that Excimer laser
combined therapy of excimer laser and tacrolimus is used rather than applying only laser therapy in Iranian population. This effect is significant despite from race, sun exposure duration and other factors which differ between populations and may influence the results of vitiligo treatment. To our knowledge this is the first study evaluating the effect of combined therapy with
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excimer laser and tacrolimus in Iranian patients with vitiligo. We recommend here to dermatologist who are working in lase centers in Iran to use combined therapy of excimer laser and tacrolimus rather than excimer laser alone. This paper can be used as a citation for those
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dermatologists who apply treatment methods in patients with vitiligo in Iran.
Although this study gives clinician a suitable evidence to cite for running laser treatments by using a matched control group but it is essential that findings of this retrograde observational study be confirmed in clinical trials in Iran. However it is considerable that as this study was based on reviews of medical files our power in determining laser therapy induced complications
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were limited to records in these files. While our retrograde observational study detected no specific complication associated with implemented treatments, declaring safety of these procedures in Iranian population may need long term follow ups investigations. Sun exposure
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duration was another factor that was not measured in this study however all included patients were inhabitants of Tehran and had comparable outdoor activity which led to relative homogenous population.
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Disclosure of Interest
We declare that there is no conflict of interest in any terms and conditions related to this paper. Disclosure
There is nothing to declare as competing interest for any of the authors including the
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Study Limitation
corresponding author. Acknowledgement
This investigation was supported by Islamic Azad University-Tehran Medical Branch, Tehran, Iran. We like to thank all staff that helped us in data collection in Behsima laser center.
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Authorship All the authors have contributed enough towards this publication to justify authorship criteria
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Copyright
Dermatology if it is accepted for publication. We warrant that this paper is original and has not been in part or in whole simultaneously submitted to or published in another journal.
Conflict of interest
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There is no conflict of interest of any of the authors with the results of this study.
Ethics committee / Institutional review board’s permission
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We also declare that the study was assessed and approved by the institutional ethics committee / institutional review board.
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Permission
Copy of permission(s), if any, to reproduce published material is enclosed.
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We transfer all copyright ownership of the enclosed manuscript to the Indian Journal of
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Passeron T, Ostovari N, Zakaria W, Fontas E, Larrouy JC, Lacour JP et al. Topical
tacrolimus and the 308-nm excimer laser: a synergistic combination for the treatment of vitiligo. Arch Dermatol 2004;140(9):1065-9. 19.
Kawalek AZ, Spencer JM, Phelps RG. Combined excimer laser and topical tacrolimus
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topical tacrolimus: a controlled prospective, randomized, observer-blined trial, J Eur Acad
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Figure 1: Outcomes of repigmentation in patients with vitiligo who underwent excimer or
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excimer+ tropical tacrolimus treatment
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Figure legends:
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Male
Female
Association
No repigmentation
63.6% (n: 14)
36.4% (n: 8)
NS
Less than 25%
37.0% (n: 10)
25-50%
57.7% (n: 15)
50-75%
53.1% (n: 17)
More than 75%
41.9% (n: 18)
63.0% (n: 17)
NS
42.3% (n: 11)
NS
46.9% (n: 15)
NS
58.1% (n:25)
NS
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NS: No significant relationship
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Repigmentation
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Table 1: Sex effect on repigmentation rate in both groups of EL and ELT
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39.77
Less than 25% Repigmentation
44.15
25%-50% Repigmentation
45.23
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No Repigmentation
50%-75% Repigmentation
49.88
More than 75% Repigmentation
49.49
Age effect significance
No Significant correlation
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The age effect was evaluated by comparison of means (mean age in each categorized group of repigmentation) by one-way analysis of variance (ANOVA)
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Table 2: Age effect on vitiligo treatment outcomes in both groups of EL and ELT Mean Age(years)
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