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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.