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J Am Acad Dermatol. 2008 Aug;59(2):334-40. doi: 10.1016/j.jaad.2008.04.019.

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

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  • 1Department of Dermatology, The University of Texas Medical School at Houston, Houston, Texas 77030, USA.

Abstract

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.

PMID:
18638631
[PubMed - indexed for MEDLINE]
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