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
|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® Spray, 0.05%.
Skin:Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis.