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Desonide foam 0.05%: safety in children as young as 3 months.

Author(s): Hebert AA, Desonide Foam Phase III Clinical Study Group

Affiliation(s): Department of Dermatology, The University of Texas Medical School at Houston, Houston, Texas 77030, USA.

Publication date & source: 2008-08, J Am Acad Dermatol., 59(2):334-40.

Publication type: Clinical Trial, Phase II; Clinical Trial, Phase III; Multicenter Study; Research Support, Non-U.S. Gov't

BACKGROUND: Desonide 0.05% was recently developed in an emulsion foam formulation. OBJECTIVE: The safety of desonide foam 0.05% in children aged 3 months to 17 years was evaluated in two phase II studies and one phase III study. METHODS: A phase II open-label study of the effect of desonide foam 0.05% on the hypothalamic-pituitary-adrenal axis was evaluated in pediatric and adolescent participants with mild-to-moderate atopic dermatitis. The phase II and III clinical efficacy studies evaluated adverse events. RESULTS: At the end of the 4-week treatment in the phase II study, 4% (3 of 75) of participants experienced mild, reversible hypothalamic-pituitary-adrenal-axis suppression. The combined safety data from the phase II and III studies revealed 6% of participants in the desonide foam group and 14% in the vehicle foam group reported adverse events (P = .0002), with application site burning as the most commonly reported adverse event (3% in the desonide foam group vs 7% in the vehicle foam group; P = .004). LIMITATIONS: The studies evaluated short-term use only. CONCLUSION: Desonide foam was safe and well tolerated in participants as young as 3 months.

Page last updated: 2008-11-03

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