An investigator-blind, randomized, 4-week, parallel-group, multicenter pilot study to compare the safety and efficacy of a nonsteroidal cream (Promiseb Topical Cream) and desonide cream 0.05% in the twice-daily treatment of mild to moderate seborrheic dermatitis of the face.

The treatment of seborrheic dermatitis includes topical antifungal agents to eradicate Malassezia spp, corticosteroids, which treat the inflammatory component of the disease and keratolytics which remove scale and crust. This study compared the efficacy of a nonsteroidal topical cream and a low-potency topical corticosteroid for the treatment of mild to moderate seborrheic dermatitis of the face in 77 volunteers randomized to twice-daily treatment with nonsteroidal cream or corticosteroid cream for up to 28 days. If the individual was rated clear by day 14, the study drug was collected and the participant was told not to use any topical products on the previously treated areas until after the 28-day follow-up visit. Both treatments were similarly effective in reducing disease severity, with approximately 90% of participants clearing or almost clear during the study. Both treatments demonstrated significant reductions in erythema, scaling, and pruritus (P < .0001). Safety in both groups was rated as excellent in more than 90%. Those using the nonsteroidal cream who cleared after 14 days of treatment were more likely to remain clear than were participants using the corticosteroid cream (P = .0173). Investigator global assessments of improvement found both study agents were essentially the same, and participants in both groups achieved clinically important improvement.

RCT Entities:   Population Interventions Outcomes