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

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.

• Authors: Adelaide A Hebert, Desonide Foam Phase III Clinical Study Group
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 59 Issue 2 Pg. 334-40 (Aug 2008) ISSN: 1097-6787 [Electronic] United States
• PMID: 18638631 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Desonide

Topics

• Administration, Cutaneous
• Adolescent
• Anti-Inflammatory Agents (administration & dosage, adverse effects)
• Child
• Child, Preschool
• Dermatitis, Atopic (drug therapy, pathology)
• Desonide (administration & dosage, adverse effects)
• Drug Administration Schedule
• Female
• Humans
• Hypothalamo-Hypophyseal System (drug effects)
• Infant
• Male
• Pituitary-Adrenal System (drug effects)
• Treatment Outcome
• United States