Amnon Biton

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)

A double-blind, placebo-controlled trial of an Aloe vera (A. barbadensis) emulsion in the treatment of seborrheic dermatitis

Various Aloe vera extracts are widely used in a variety of over-the-counter skin products, but only a few studies have been conducted to provide support for the use of Aloe vera (A. barbadensis), one of the most commonly used species of Aloe vera, in the treatment of inflammatory skin conditions. Seborrheic dermatitis is a common inflammatory skin disorder for which available topical treatment may be helpful but not curative. The objective of this study was to evaluate the effect of an emulsion formulated from a crude extract of Aloe vera (A. barbadensis) on seborrheic dermatitis. A double-blind, randomized, placebo-controlled prospective clinical trial was performed in 44 adult patients with seborrheic dermatitis. A comparison of symptom scores in the Aloe vera (A. barbadensis) and placebo groups, before and after treatment revealed a significant decrease in scaliness, pruritus and the number of sites involved in seborrheic dermatitis, but not in erythema. Global improvement rates in patients treated wit...

An independent comparison of terbinafine and itraconazole in the treatment of toenail onychomycosis

BACKGROUND: Previously, sponsored publications have shown that either terbinafine or itraconazole (pulse regimen) are effective for patients with toenail onychomycosis. However, independent comparative studies are lacking. OBJECTIVES: To objectively compare treatment with terbinafine and itraconazole in patients with toenail onychomycosis. METHODS: The effectiveness of terbinafine (250 mg/day 3 months) versus itraconazole pulse regimen (400 mg/day for the first week of each month, for three cycles) was retrospectively evaluated in patients with toenail onychomycosis using mycological tests and subjective outcome measures. Statistical analyses were performed using one‐way analyses of variance (ANOVA) for continuous variables and Fisher exact tests for categorical variables. RESULTS: Included in the study were 117 patients (74 patients treated by terbinafine and 43 patients treated with itraconazole). Patients were examined at an average period of 20 months after the end of therapy. Mycological cure was observed in 70.6% and 62.8% of the patients who were treated by terbinafine or itraconazole, respectively (not statistically significant). Mean visual analogue scale assessment of treatment outcome was 79.9 mm (SD 24.7 mm) and 65.2 mm (SD 34.6 mm) for patients treated by terbinafine or itraconazole, respectively (p=0.008). When the results were stratified according to age and gender, it was observed that the advantage of terbinafine versus itraconazole retained statistical significance only for patients who were 55 years old and above, or females. CONCLUSIONS: Mycological cure proportions were not statistically significant between patients treated by terbinafine or itraconazole for toenail onychomycosis. However, better subjective outcome measures indicated an advantage for terbinafine over itraconazole, noticeable in females and patients 55 years old and above.