1116
Brief communications
REFERENCES
1. Steere AC, Malawista SE, Bartcnhagen NR, et al. The clinical spectrum and treatment of Lyme disease. Yale J Bioi Med 1984;57:453-61. 2. Berger BW. Erythema chronicum migrans of Lyme disease. Arch DermatoI1984;120:1017-21. 3. Kramer N, Rickert RR, Brodkin RH, et al. Septal panniculitis as a manifestation of Lyme disease. Am J Med 1986; 81:149-52. 4. Eichenfield AR, Goldsmith DP, Benach JL, et al. Childhood Lyme arthritis: experience in endemic area. J Pediatr 1986; 109:753-8. 5. Russell H, Sampson JS, Schmid GP, et al. Enzyme-linked immunosorbent assay and indirect immunofluorescence assay for Lyme disease. ] Infect Dis 1984;149:465-70. 6. Duffy J, Mertz LE, Wobig GH, et al. Diagnosing Lyme disease: the contribution of serologic testing. Mayo Clin Proc 1988;63: 1116-21. 7. Gammon WR. Urticarial vasculitis. Dermatol Clin 1985; 3:97-105. 8. Monroe EW, Schulz CI, Maize JC, et al. Vasculitis in chronic urticaria: an immunopathologic study. J Invest DcrmatoI1981;76:103-7. 9. Midgard R, Hofstad R. Unusual manifestations of nervous system Borrelia burgdorferi infection. Arch Neurol J987; 44:781-3. 10. Camponovo F, Meier C. Neuropathy of vasculitic origin in a case of Garin-Boujadoux-Bannwarth syndrome with positive Borrelia antibody response. J Ncurol 1986;233: 69-72.
Comparison of once- and twice-daily naftifine cream regimens with twice-daily clotrimazole in the treatment of tinea pedis Edgar B. Smith, MD,a Karen Wiss, MD,a Jon M. Hanifin, MD,b Robert E. Jordon, MD,c Ronald P. Rapini, MD,e Alan E. Lasser, MD,d M. Barry Kirschenbaum, MD,e Larry E. Millikan, MD,f Lawrence Charles Parish, MD,g Marvin J. Rapaport, MD,h Henry Roenigk, Jr., MD,i Nardo Zaias, MD,j Sydney H. Dromgoole, PhD,k John Sefton, PhD,k Ronald DeGryse, MS,k and Frank P. Killey, PhDkHouston and Galveston,
Texas, Portland, Oregon, Skokie and Chicago, Illinois, New Orleans, Louisiana, Philadelphia, Pennsylvania, Beverly Hills and Irvine, California, and Miami Beach, Florida From the University of Texas Medical Branch, Galveston"; Oregon Health Sciences University, Portland"; University of Texas Health Science Center, Houstorr'; Skokie''; Chicago"; Tulane University MedicalCenter, NewOrleans';JeffersonMedical CollegeofThomas Jefferson University, Philadelphias; Beverly I-Iillsh; Northwestern Medical School, Chicago'; Miami Beacl~; and Herbert Laboratories, Irvine," Reprint requests:Sydney H. Dromgoole, PhD, Herbert Laboratories, 2525 Dupont Dr. Irvine, CA 92715.
16/4/16643
Journal of the American Academy of Derma tology
Naftifine, a topical allylamine with broad-spectrum antifungal activity, has been approved in the United States for twice-daily treatment of tinea pedis, tinea cruris, and tinea corporis. Preliminary studies conducted in Europe have suggested that naftifine may also be effective in a once-daily regimen.l-' Our double-blind, multicenter study compared naftifine 1% cream (Naftin, Herbert Laboratories, Irvine, Calif.), applied once or twice daily, and twice-daily clotrimazole 1% cream (Lotrimin, Schering Corp., Kenilworth, N.J.) in the treatment of tinea pedis. Methods. The study population included 155 male and 55 female patients whose ages ranged from 14 to 78 years (mean 40.2 years). The diagnosis of tinea pedis was confirmed by KOH microscopy and culture. Culture results revealed the presence of the following dermatopnytes: Trichophyton rubrum, T. mentagrophytes, Epidermophytonfioccosum, and T. terrestre. Of the dermatophytcs identified, 84% were T. rubrum and 12% were T. mentagrophytes. After randomized assignment to treatment groups (89 patients to the naftifine once-daily group, 50 to the naftifine (twice-daily group, and 71 to the clotrimazole twice-daily group), patients were instructed to apply their cream preparation twice daily for 4 weeks. The patients in the once-daily naftifine group received cream vehicle during one of the two daily applications. KOH microscopy, fungal culture, and an assessment of signs and symptoms of tinea pedis were performed after 2 and 4 weeks of treatment and again 2 weeks after treatment. A subgroup of patients with hyperkeratotic plantar-type tinea pedis was also seen 4 weeks after treatment.
Results. All three regimens reduced the incidence and severity of tinea pedis symptoms and were well tolerated by the patients. By the posttreatment examination at week 6, treatment success (defined as normal microscopy findings, negative culture, and no or only mild residual signs and symptoms) had been achieved in 81 % of the patients in the naftifine twice-daily group compared with 58% of the clotrimazole twice-daily group (p = 0.026; Table I). Differences were found favoring naftifine once or twice daily over clotrimazole in the resolution of certain signs and symptoms (Fig. 1). After 4 weeks of treatment, significantly higher percentages of patients using naftifine once daily than clotrimazole twice daily were free of erythema (81 % vs 61%;p = O.QlI) and fissuring (95% vs 83%; P = 0.033). In addition, significantly more patients in the naftifine twice-daily group than in the clotrimazole twice-daily group were free of erythema (85% vs 61 %; P = 0.015) and pruritus (97% vs 80%; p = 0.022) by the end of treatment. No significant differences were noted between naftifine once daily and naftifine twice daily in rate of treatment success or resolution of signs and symptoms. Twenty patients with hyperkeratotic plantar-type tinea pedis were enrolled in the study; only 13 generated evaluable data 4 weeks after the end of treatment. Treatment
Volume 22 Number 6, Part 1 June 1990
Briefcommunications 1117 p
~
0.011
pI#- 0.033
p
v
0022·
100
80
~ Nanilme q.d .
% ot Patients 40
•
Namfine b.i.c,
o
Clommaaote b.i.d.
20
EI}'lhema
Fissuring
Prurilus
Fig. 1. Percentage ofpatientsfreeof erythema, fissuring, and pruritus after a 4-weekcourse of treatment with naftifineonce daily, naftifine twice daily, or clotrimazole twice daily.
Table I. Treatment success rate (mycologic cure and no or only mild residual signs and symptoms) Week
Treatment 2 4 Posttreatment 6
Nartifine q.d, (No. of patients)
Naftifine b.l.d, (No. of patients)
Clotrimazole b.l.d, (No. of patients)
33% (25/76) 60% (48/80)
27% (11/41) 67% (30/45)
32% (22/68) 51% (34/67)
66% (43/65)
81% (29/36)*
58% (32/55)
*p = 0.026 versus clotrirnazole bid.
success was documentedin five of sevenpatientswhohad used naftifineonce daily, both of two whohad used naftifine twicedaily, and only one of four whohad used clotrimazole twice daily. Side effects were infrequent,affecting four patientsin each of the twonaftifinegroupsand three in the clotrimazole group, and were mild or moderate in severity. In only three cases, one in each group,did sideeffects (blisters or increased scalingwith naftifineoncedaily,contact dermatitis with naftifine twice daily, and vesicular flare with clotrimazole twice daily) necessitate withdrawal of patients from the study. Comment. The success of topical antifungal therapy depends not only on the pharmacologic efficacy of the agents administered but also on the patient's compliance with the prescribed regimen. Becausecurrent antifungal agents, including naftifine, are highly effective against tinea pedis, suitabilityfor use in a simplified regimen becomes an important criterion for drug selection. A topicalantifungalmedication that could be used effectively on a once-daily basis to treat tinea pedis promises topromote patient compliance and thereby help ensure the desired therapeutic outcome. The results of our study confirm preliminary findings!" that naftifine used once daily is effective against tinea pedis and suggest that it may be more effective than clotrimazoleused twicedaily.
REFERENCES 1. Effendy I, Friederich He. Double-blind, randomized, comparative trial of naftitine solution (once daily) and clotrimazole solution (twice daily) in the treatment of dermatomycoses. Mykosen 1987;30(suppl 1):104-11. 2. Meinicke K, Striegel C, Weidinger G. Treatment of dermatomycoses with naftifine: therapeutic efficacy of application once daily and twice daily. Mykosen 1987;30(suppl 1):98-103. 3. Polcmann G. Antifungal efficacy of naftifine applied once daily. Mykosen 1987;30(suppl 1):92-7.
Dermatitis herpetiformis and AIDS-related complex A. Hasson, MD,a M. C. Gutierrez, MD,a 1. Martin, MD,a A. Barat, MD,b and A. Castro, MIY Madrid, Spain We add another case to that reported by Mitsuhashi and Hohl! of a patient with dermatitis herpetiformis and acquired immunodeficiency syndrome (AIDS)-related complex. From the Departments of Dermatology" and Pathology.l' Fundacion Jimenez Diaz, Universidad Autonoma. Reprint requests: A. Hasson, MD, Servicio de Derrnatologla, Fundaci6n Jimenez Diaz, Avda. Reyes Cat6licos 2. 28040 Madrid, Spain.
16/4/16677
Brief communications
REFERENCES
1. Steere AC, Malawista SE, Bartcnhagen NR, et al. The clinical spectrum and treatment of Lyme disease. Yale J Bioi Med 1984;57:453-61. 2. Berger BW. Erythema chronicum migrans of Lyme disease. Arch DermatoI1984;120:1017-21. 3. Kramer N, Rickert RR, Brodkin RH, et al. Septal panniculitis as a manifestation of Lyme disease. Am J Med 1986; 81:149-52. 4. Eichenfield AR, Goldsmith DP, Benach JL, et al. Childhood Lyme arthritis: experience in endemic area. J Pediatr 1986; 109:753-8. 5. Russell H, Sampson JS, Schmid GP, et al. Enzyme-linked immunosorbent assay and indirect immunofluorescence assay for Lyme disease. ] Infect Dis 1984;149:465-70. 6. Duffy J, Mertz LE, Wobig GH, et al. Diagnosing Lyme disease: the contribution of serologic testing. Mayo Clin Proc 1988;63: 1116-21. 7. Gammon WR. Urticarial vasculitis. Dermatol Clin 1985; 3:97-105. 8. Monroe EW, Schulz CI, Maize JC, et al. Vasculitis in chronic urticaria: an immunopathologic study. J Invest DcrmatoI1981;76:103-7. 9. Midgard R, Hofstad R. Unusual manifestations of nervous system Borrelia burgdorferi infection. Arch Neurol J987; 44:781-3. 10. Camponovo F, Meier C. Neuropathy of vasculitic origin in a case of Garin-Boujadoux-Bannwarth syndrome with positive Borrelia antibody response. J Ncurol 1986;233: 69-72.
Comparison of once- and twice-daily naftifine cream regimens with twice-daily clotrimazole in the treatment of tinea pedis Edgar B. Smith, MD,a Karen Wiss, MD,a Jon M. Hanifin, MD,b Robert E. Jordon, MD,c Ronald P. Rapini, MD,e Alan E. Lasser, MD,d M. Barry Kirschenbaum, MD,e Larry E. Millikan, MD,f Lawrence Charles Parish, MD,g Marvin J. Rapaport, MD,h Henry Roenigk, Jr., MD,i Nardo Zaias, MD,j Sydney H. Dromgoole, PhD,k John Sefton, PhD,k Ronald DeGryse, MS,k and Frank P. Killey, PhDkHouston and Galveston,
Texas, Portland, Oregon, Skokie and Chicago, Illinois, New Orleans, Louisiana, Philadelphia, Pennsylvania, Beverly Hills and Irvine, California, and Miami Beach, Florida From the University of Texas Medical Branch, Galveston"; Oregon Health Sciences University, Portland"; University of Texas Health Science Center, Houstorr'; Skokie''; Chicago"; Tulane University MedicalCenter, NewOrleans';JeffersonMedical CollegeofThomas Jefferson University, Philadelphias; Beverly I-Iillsh; Northwestern Medical School, Chicago'; Miami Beacl~; and Herbert Laboratories, Irvine," Reprint requests:Sydney H. Dromgoole, PhD, Herbert Laboratories, 2525 Dupont Dr. Irvine, CA 92715.
16/4/16643
Journal of the American Academy of Derma tology
Naftifine, a topical allylamine with broad-spectrum antifungal activity, has been approved in the United States for twice-daily treatment of tinea pedis, tinea cruris, and tinea corporis. Preliminary studies conducted in Europe have suggested that naftifine may also be effective in a once-daily regimen.l-' Our double-blind, multicenter study compared naftifine 1% cream (Naftin, Herbert Laboratories, Irvine, Calif.), applied once or twice daily, and twice-daily clotrimazole 1% cream (Lotrimin, Schering Corp., Kenilworth, N.J.) in the treatment of tinea pedis. Methods. The study population included 155 male and 55 female patients whose ages ranged from 14 to 78 years (mean 40.2 years). The diagnosis of tinea pedis was confirmed by KOH microscopy and culture. Culture results revealed the presence of the following dermatopnytes: Trichophyton rubrum, T. mentagrophytes, Epidermophytonfioccosum, and T. terrestre. Of the dermatophytcs identified, 84% were T. rubrum and 12% were T. mentagrophytes. After randomized assignment to treatment groups (89 patients to the naftifine once-daily group, 50 to the naftifine (twice-daily group, and 71 to the clotrimazole twice-daily group), patients were instructed to apply their cream preparation twice daily for 4 weeks. The patients in the once-daily naftifine group received cream vehicle during one of the two daily applications. KOH microscopy, fungal culture, and an assessment of signs and symptoms of tinea pedis were performed after 2 and 4 weeks of treatment and again 2 weeks after treatment. A subgroup of patients with hyperkeratotic plantar-type tinea pedis was also seen 4 weeks after treatment.
Results. All three regimens reduced the incidence and severity of tinea pedis symptoms and were well tolerated by the patients. By the posttreatment examination at week 6, treatment success (defined as normal microscopy findings, negative culture, and no or only mild residual signs and symptoms) had been achieved in 81 % of the patients in the naftifine twice-daily group compared with 58% of the clotrimazole twice-daily group (p = 0.026; Table I). Differences were found favoring naftifine once or twice daily over clotrimazole in the resolution of certain signs and symptoms (Fig. 1). After 4 weeks of treatment, significantly higher percentages of patients using naftifine once daily than clotrimazole twice daily were free of erythema (81 % vs 61%;p = O.QlI) and fissuring (95% vs 83%; P = 0.033). In addition, significantly more patients in the naftifine twice-daily group than in the clotrimazole twice-daily group were free of erythema (85% vs 61 %; P = 0.015) and pruritus (97% vs 80%; p = 0.022) by the end of treatment. No significant differences were noted between naftifine once daily and naftifine twice daily in rate of treatment success or resolution of signs and symptoms. Twenty patients with hyperkeratotic plantar-type tinea pedis were enrolled in the study; only 13 generated evaluable data 4 weeks after the end of treatment. Treatment
Volume 22 Number 6, Part 1 June 1990
Briefcommunications 1117 p
~
0.011
pI#- 0.033
p
v
0022·
100
80
~ Nanilme q.d .
% ot Patients 40
•
Namfine b.i.c,
o
Clommaaote b.i.d.
20
EI}'lhema
Fissuring
Prurilus
Fig. 1. Percentage ofpatientsfreeof erythema, fissuring, and pruritus after a 4-weekcourse of treatment with naftifineonce daily, naftifine twice daily, or clotrimazole twice daily.
Table I. Treatment success rate (mycologic cure and no or only mild residual signs and symptoms) Week
Treatment 2 4 Posttreatment 6
Nartifine q.d, (No. of patients)
Naftifine b.l.d, (No. of patients)
Clotrimazole b.l.d, (No. of patients)
33% (25/76) 60% (48/80)
27% (11/41) 67% (30/45)
32% (22/68) 51% (34/67)
66% (43/65)
81% (29/36)*
58% (32/55)
*p = 0.026 versus clotrirnazole bid.
success was documentedin five of sevenpatientswhohad used naftifineonce daily, both of two whohad used naftifine twicedaily, and only one of four whohad used clotrimazole twice daily. Side effects were infrequent,affecting four patientsin each of the twonaftifinegroupsand three in the clotrimazole group, and were mild or moderate in severity. In only three cases, one in each group,did sideeffects (blisters or increased scalingwith naftifineoncedaily,contact dermatitis with naftifine twice daily, and vesicular flare with clotrimazole twice daily) necessitate withdrawal of patients from the study. Comment. The success of topical antifungal therapy depends not only on the pharmacologic efficacy of the agents administered but also on the patient's compliance with the prescribed regimen. Becausecurrent antifungal agents, including naftifine, are highly effective against tinea pedis, suitabilityfor use in a simplified regimen becomes an important criterion for drug selection. A topicalantifungalmedication that could be used effectively on a once-daily basis to treat tinea pedis promises topromote patient compliance and thereby help ensure the desired therapeutic outcome. The results of our study confirm preliminary findings!" that naftifine used once daily is effective against tinea pedis and suggest that it may be more effective than clotrimazoleused twicedaily.
REFERENCES 1. Effendy I, Friederich He. Double-blind, randomized, comparative trial of naftitine solution (once daily) and clotrimazole solution (twice daily) in the treatment of dermatomycoses. Mykosen 1987;30(suppl 1):104-11. 2. Meinicke K, Striegel C, Weidinger G. Treatment of dermatomycoses with naftifine: therapeutic efficacy of application once daily and twice daily. Mykosen 1987;30(suppl 1):98-103. 3. Polcmann G. Antifungal efficacy of naftifine applied once daily. Mykosen 1987;30(suppl 1):92-7.
Dermatitis herpetiformis and AIDS-related complex A. Hasson, MD,a M. C. Gutierrez, MD,a 1. Martin, MD,a A. Barat, MD,b and A. Castro, MIY Madrid, Spain We add another case to that reported by Mitsuhashi and Hohl! of a patient with dermatitis herpetiformis and acquired immunodeficiency syndrome (AIDS)-related complex. From the Departments of Dermatology" and Pathology.l' Fundacion Jimenez Diaz, Universidad Autonoma. Reprint requests: A. Hasson, MD, Servicio de Derrnatologla, Fundaci6n Jimenez Diaz, Avda. Reyes Cat6licos 2. 28040 Madrid, Spain.
16/4/16677
