Clinical Trials Experience
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® Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with CLOBEX® Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for CLOBEX® 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.
Postmarketing Experience
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® Spray, 0.05%.
Skin:Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis.