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Safety and efficacy of desonide hydrogel 0.05% in pediatric subjects with atopic dermatitis

Adelaide A Hebert1, Fran E Cook-Bolden, Sarmistha Basu

  • 1Department of Dermatology, University of Texas Medical School, Houston, TX, USA.

Journal of Drugs in Dermatology : JDD
|March 22, 2007
PubMed

Insights

A new desonide hydrogel formulation offers a safe and effective treatment for atopic dermatitis (AD) in children. This novel topical steroid demonstrated significant improvements in mild to moderate AD cases, proving well-tolerated in pediatric subjects.

Area of Science:

  • Dermatology
  • Pediatric Medicine
  • Pharmacology

Background:

  • Atopic dermatitis (AD) is a chronic skin condition prevalent in children.
  • Low to mid-potency corticosteroids are standard treatments for AD.
  • Safety is a critical concern for pediatric patients, especially those under two years old.

Purpose of the Study:

  • To evaluate the safety and efficacy of a novel desonide (0.05%) aqueous hydrogel formulation.
  • To assess the new formulation in pediatric subjects with mild to moderate atopic dermatitis.

Main Methods:

  • Two Phase III clinical trials were conducted.
  • 425 pediatric subjects (3 months to 18 years) received desonide hydrogel 0.05%.
  • 157 subjects received the hydrogel vehicle; safety and efficacy endpoints were measured.

Main Results:

  • Desonide hydrogel 0.05% was extremely well-tolerated in pediatric subjects.
  • Statistically significant improvements were observed in primary efficacy endpoints (P < .001).
  • Statistically significant improvements were observed in secondary efficacy endpoints (P < .006).

Conclusions:

  • The novel desonide hydrogel formulation is a safe and effective treatment option for pediatric atopic dermatitis.
  • This formulation represents an advancement in topical steroid therapy for AD in young patients.
  • The alcohol- and surfactant-free hydrogel base enhances tolerability.

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