Desonide foam 0.05%: Safety in children as young as 3 months - 24/04/13
Desonide Foam Phase III Clinical Study Group
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.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AD, AE, BSA, FDA, HPA, ISGA
Plan
Supported by Stiefel Laboratories Inc. |
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Disclosure: The principal authors have served as clinical investigators on other studies sponsored by Stiefel Laboratories Inc. |
Vol 59 - N° 2
P. 334-340 - août 2008 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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