SEOUL, KOREA – Twice-weekly clobetasol shampoo alternating with twice-weekly ketoconazole shampoo is a highly effective and well-tolerated treatment for moderate to severe seborrheic dermatitis, a multicenter randomized clinical trial indicates.
The superior efficacy of the combined regimen as compared to monotherapy with either agent alone was sustained with once-weekly ketoconazole shampoo maintenance therapy, Dr. Jean-Paul Ortonne reported at the World Congress of Dermatology.
The 22-center, 12-week study was conducted in Europe, North America, and Asia, and included 326 patients with moderate to severe scalp seborrheic dermatitis. At baseline, 61% of participants had involvement of at least 50% of their scalp.
Subjects were randomized to one of four treatment regimens: alternate weeks of clobetasol propionate shampoo 0.05% twice weekly and ketoconazole shampoo 2% twice weekly for 4 weeks; 4 weeks of either agent alone twice weekly; or clobetasol shampoo four times per week alternating with ketoconazole shampoo twice weekly for 4 weeks. The 4-week treatment phase was followed by 4 weeks of once-weekly ketoconazole shampoo maintenance therapy, then 4 additional weeks of untreated follow-up.
All three clobetasol-containing regimens were significantly more effective than twice-weekly ketoconazole monotherapy in reducing total severity scores at weeks 2 and 4. Indeed, 80%-90% of patients on the three clobetasol-containing regimens had no or only mild erythema, scaling, and itching at week 4, and median severity scores in the three clobetasol-containing regimens had dropped by roughly 70% compared with baseline, according to Dr. Ortonne, professor and chairman of the department of dermatology at the University of Nice–Sophia Antipolis (France).
By week 8, after 4 weeks of ketoconazole shampoo maintenance therapy, the groups earlier on clobetasol monotherapy or clobetasol four times weekly alternating with ketoconazole twice weekly both demonstrated slight worsening in terms of total severity scores, as well as measures of erythema, scaling, and itch. In contrast, efficacy was sustained throughout the maintenance phase in patients earlier assigned to clobetasol twice weekly alternating with ketoconazole twice weekly.
At week 12, after 4 weeks without treatment, efficacy remained highest in the twice-weekly alternating clobetasol/ketoconazole group, the majority of whom had involvement of less than 30% of their scalp area and no or only mild erythema, scaling, and pruritus.
The 4.9% treatment-related adverse event rate was similar in all four treatment arms and consisted mostly of mild burning. No worsening of skin atrophy was observed with any of the regimens. Two patients in the twice-weekly alternating clobetasol/ketoconazole group reported developing mild telangiectasias during the study.
Dr. Ortonne is a consultant to Galderma, the study sponsor.