Abstract | BACKGROUND: 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.
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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)
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Chemical References |
- Anti-Inflammatory Agents
- Desonide
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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
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