ADVERSE REACTIONS
In clinical trials with CLOBEX™ Shampoo, the following adverse reactions have been reported: burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.
The table below summarizes selected adverse events that occurred in
at least
1% of subjects in the Phase 2 and 3 studies for scalp psoriasis.
Summary of Selected Adverse Events >/= 1% by
Body System
|
Body System
|
Clobetasol
Propionate
Shampoo N=558
|
Vehicle Shampoo
N=127
|
|
Skin and Appendages
|
49 (8.8%) |
28 (22.0%) |
|
Discomfort Skin
|
26 (4.7%) |
16 (12.6%) |
|
Pruritus
|
3 (0.5%) |
9 (7.1%) |
|
Body As A Whole
|
33 (5.9%) |
12 (9.4%) |
|
Headache
|
10 (1.8%) |
1 (0.8%) |
|
The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
|
