In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of OLUX (clobetasol propionate) Foam therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with OLUX (clobetasol propionate) Foam. (See Table 3 below.)
Table 3: Subjects with reversible HPA axis suppression at any time during treatment
|Psoriasis||1 of 9|
|Atopic Dermatitis*||4 of 4|
|*OLUX Foam is not indicated for non-scalp atopic dermatitis, as the safety and efficacy of OLUX Foam in non-scalp atopic dermatitis has not been established. Use in children under 12 years of age is not recommended.|
Systemic absorption of topical corticosteroids has produced reversible adrenal suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients (see PRECAUTIONS).
In a controlled clinical trial (188 subjects) with OLUX (clobetasol propionate) Foam in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the OLUX (clobetasol propionate) Foam treated subjects. In two controlled clinical trials (360 subjects) with OLUX (clobetasol propionate) Foam in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the OLUX (clobetasol propionate) Foam treated subjects included application site burning (10%), application site dryness ( < 1%), and other application site reactions (4%).
In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).
The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as OLUX (clobetasol propionate) Foam. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.