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


CONCLUSIONS
The studies evaluated short-term use only.


CONCLUSIONS
Desonide foam was safe and well tolerated in participants as young as 3 months.
Hebert
Adelaide A
AA
Department of Dermatology, The University of Texas Medical School at Houston, Houston, Texas 77030, USA.
D000279:Administration, Cutaneous; D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000473:pathology; D003898:Desonide / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects; D007223:Infant; D008297:Male; D010913:Pituitary-Adrenal System / Q000187:drug effects; D016896:Treatment Outcome; D014481:United States
D000893:Anti-Inflammatory Agents; D003898:Desonide