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

Adelaide A Hebert1,

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

Journal of the American Academy of Dermatology
|July 22, 2008
PubMed

Insights

Desonide foam 0.05% demonstrated safety and tolerability in pediatric patients aged 3 months to 17 years. Mild, reversible hypothalamic-pituitary-adrenal axis suppression was observed in a small percentage of participants.

Area of Science:

  • Dermatology
  • Pediatric Endocrinology

Background:

  • Desonide 0.05% is a new emulsion foam formulation.
  • Topical corticosteroids are commonly used for inflammatory skin conditions.

Purpose of the Study:

  • To evaluate the safety and tolerability of desonide foam 0.05% in pediatric patients.
  • Assessed the impact of desonide foam on the hypothalamic-pituitary-adrenal axis.

Main Methods:

  • Conducted two Phase II and one Phase III clinical studies.
  • Included pediatric and adolescent participants aged 3 months to 17 years with mild-to-moderate atopic dermatitis.
  • Monitored adverse events and hypothalamic-pituitary-adrenal axis function.

Main Results:

  • 4% of participants experienced mild, reversible hypothalamic-pituitary-adrenal axis suppression after 4 weeks of treatment.
  • Adverse events were reported in 6% of the desonide foam group versus 14% of the vehicle foam group (P = .0002).
  • Application site burning was the most frequent adverse event, occurring in 3% of the desonide foam group and 7% of the vehicle foam group (P = .004).

Conclusions:

  • Desonide foam 0.05% is safe and well-tolerated in pediatric patients as young as 3 months.
  • The studies focused on short-term use of the medication.
Abstract

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