Clinical Trials Experience
In controlled clinical trials involving 821 subjects exposed to Olux-E (clobetasol propionate foam) Foam
and Vehicle Foam, the pooled incidence of local adverse reactions in trials
for atopic dermatitis and psoriasis with Olux-E (clobetasol propionate foam) Foam was 1.9% for application
site atrophy and 1.6% for application site reaction. Most local adverse events
were rated as mild to moderate and they were not affected by age, race, or gender.
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly
compared to rates in the clinical trials of another drug and may not reflect
the rates observed in clinical practice.
The following additional local adverse reactions have been reported with topical
corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral
dermatitis, allergic contact dermatitis, secondary infection, irritation, striae,
and miliaria. They may occur more frequently with the use of occlusive dressings
and higher potency corticosteroids, such as clobetasol propionate.
Cushing's syndrome has been reported in infants and adults as a result of prolonged
use of topical clobetasol propionate formulations.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use
of clobetasol formulations: erythema, pruritus, burning, alopecia, and dryness.
Because these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or establish
a causal relationship to drug exposure.