A double-blind, placebo-controlled trial of a ciclopirox olamine 1% shampoo for the treatment of scalp seborrheic dermatitis

BACKGROUND: Ciclopirox olamine is a broad spectrum antifungal agent that has been shown to be effective in treating various cutaneous fungal infections. However, little information is available on the effect of ciclopirox olamine on seborrheic dermatitis, a common skin disorder associated with increased cutaneous fungal density. AIM: The purpose of the study was to determine the effectiveness and safety of 1% ciclopirox olamine shampoo for the treatment of scalp seborrheic dermatitis. METHODS: The study was designed as a prospective, double-blind, randomized, placebo-controlled clinical study and was performed in the dermatology institute of Clalit Health Services, southern district, Israel. Patients were randomly divided into a ciclopirox olamine shampoo treatment group and a placebo (vehicle) shampoo treatment group. The shampoo was applied twice a week, 5 min for each application (after first shampooing and rinsing the hair). Patients were treated for a period of 4 weeks and examined on enrollment, after 2 weeks, after 4 weeks (end of treatment) and at the end of 6 weeks (follow-up examination). The main outcome measures were severity of seborrheic dermatitis symptoms and the overall assessment of response to treatment by both the physician and patient. RESULTS: Of the 102 patients enrolled in the study, 82 patients completed the full trial protocol. A total of 93% of the patients in the ciclopirox olamine group improved or cleared compared with 41% of the patients in the placebo group at the end of 4 weeks of treatment ( P < 0.00001). There were no significant side-effects during treatment and no recurrence was observed 2 weeks after cessation of treatment. Comparison of severity scores showed a significant reduction (at a significantly higher rate) in scalp seborrheic dermatitis symptoms in the ciclopirox group compared with the placebo group and compared with baseline scores. CONCLUSION: We conclude that 1% ciclopirox olamine shampoo is an effective and safe treatment of scalp seborrheic dermatitis. (J Dermatol Treat (2000) 11:73-77)

[1]  Parry,et al.  Seborrhoeic dermatitis is not caused by an altered immune response to Malassezia yeast , 1998, The British journal of dermatology.

[2]  D. Shuttleworth,et al.  A double-blind, placebo-controlled study of the clinical efficacy of ciclopirox olamine (1.5%) shampoo for the control of scalp psoriasis , 1998 .

[3]  K. Goode,et al.  Comparative clinical efficacy of shampoos containing ciclopirox olamine (1.5%) or ketoconazole (2%; Nizoral®) for the control of dandruff/seborrhoeic dermatitis , 1998 .

[4]  M. Mimouni,et al.  Treatment with Bifonazole Shampoo for Scalp Seborrhea in Infants and Young Children , 2010, Pediatric dermatology.

[5]  P. Koch,et al.  Allergic contact dermatitis from cyclopiroxolamine? , 1995, Contact dermatitis.

[6]  U. Richarz-Barthauer,et al.  Successful treatment and prophylaxis of scalp seborrhoeic dermatitis and dandruff with 2% ketoconazole shampoo: results of a multicentre, double‐blind, placebo‐controlled trial , 1995, The British journal of dermatology.

[7]  W. Cunliffe,et al.  Cell‐mediated immune responses to Malassezia furfur serovars A, B and C in patients with pityriasis versicolor, seborrheic dermatitis and controls , 1994, Experimental dermatology.

[8]  D. Rosenthal,et al.  A randomized, double-blind, placebo-controlled trial of ketoconazole 2% shampoo versus selenium sulfide 2.5% shampoo in the treatment of moderate to severe dandruff. , 1993, Journal of the American Academy of Dermatology.

[9]  A. Ingber,et al.  Treatment with bifonazole shampoo for seborrhea and seborrheic dermatitis: a randomized, double-blind study. , 1992, Acta dermato-venereologica.

[10]  T. Hoehler,et al.  Ciclopirox olamine: a hydroxypyridone antifungal agent. , 1991, Clinics in dermatology.

[11]  A. Scheynius,et al.  An immunological study in patients with seborrhoeic dermatitis , 1991, Clinical and experimental dermatology.

[12]  D. Barker,et al.  Correlation of Pityosporum ovale density with clinical severity of seborrheic dermatitis as assessed by a simplified technique. , 1990, Journal of the American Academy of Dermatology.

[13]  H. Maibach,et al.  Ciclopirox olamine lotion 1%: bioequivalence to ciclopirox olamine cream 1% and clinical efficacy in tinea pedis. , 1989, Clinical therapeutics.

[14]  A. Shalita,et al.  Multicentre Double-Blind Clinical Trials of Ciclopirox Olamine Cream 1% in the Treatment of Tinea Corporis and Tinea Cruris , 1986, The Journal of international medical research.

[15]  R. N. Brogden,et al.  Ciclopirox olamine 1% cream. A preliminary review of its antimicrobial activity and therapeutic use. , 1985, Drugs.

[16]  V. N. Sehgal,et al.  Ciclopirox: a new topical pyrodonium antimycotic agent , 1976, The British journal of dermatology.