Psoriasis is a noncontagious skin condition that produces red, dry plaques of thickened skin. The dry flakes and skin scales are thought to result from the rapid proliferation of skin cells that is triggered by abnormal lymphocytes from the blood . Psoriasis commonly affects the skin of the elbows, knees, and scalp.
Some people have such mild ps...
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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 practice.
In controlled, clinical trials with CLOBEX® (clobetasol propionate spray) Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with CLOBEX® (clobetasol propionate spray) Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for CLOBEX® (clobetasol propionate spray) Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1.
Table 1 : Commonly Occurring Adverse Reactions ( ≥ 1% Incidence)
| Adverse Reaction | Clobetasol Propionate 0.05% Spray (N=120) |
Vehicle Spray (N=120) |
| System Organ Class | ||
| General disorders and administration site conditions | 50 (42%) | 56 (47%) |
| Application site burning | 48 (40%) | 56 (47%) |
| Application site dryness | 2 (2%) | 0 (0%) |
| Application site irritation | 1 (1%) | 0 (0%) |
| Application site pain | 1 (1%) | 2 (2%) |
| Application site pigmentation changes | 1 (1%) | 0 (0%) |
| Application site pruritus | 4 (3%) | 3 (3%) |
| Infections and infestations | 17 (14%) | 12 (10%) |
| Nasopharyngitis | 6 (5%) | 3 (3%) |
| Pharyngitis streptococcal | 1 (1%) | 0 (0%) |
| Upper respiratory tract infection | 10 (8%) | 2 (2%) |
| Skin and subcutaneous tissue disorders | 4 (3%) | 2 (2%) |
| Eczema asteatotic | 2 (2%) | 0 (0%) |
Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender.
Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
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.
The following adverse reactions have been identified during post-approval use of CLOBEX® (clobetasol propionate spray) Spray, 0.05%.
Skin: Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis.
No information provided.
Last reviewed on RxList: 2/25/2011
This monograph has been modified to include the generic and brand name in many instances.
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