Clobex® Lotion – Silky Feel, Powerful Results

In clinical trials with psoriasis patients, Clobex® Lotion proved to be as efficacious as clobetasol cream, but patients judged Clobex® Lotion to be cosmetically superior to the cream formulation.1

Clobex® Lotion Efficacy in Atopic Dermatitis

The efficacy of Clobex® Lotion, 0.05% in Atopic Dermatitis has been demonstrated in a study with 224 patients where patients treated with Clobex® Lotion for 2 weeks, showed reduction in erythema and papules compared to the patient treated with the clobetasol propionate cream, 0.05%. Also, significantly more patients treated with Clobex® Lotion stayed free of pruritus 2 weeks post-treatment, compared with patients treated with the clobertasol propionate cream. The efficacy of Clobex® Lotion, 0.05% in psoriasis has been demonstrated in several well-controlled clinical trials. The first study was conducted in patients with moderate to severe plaque psoriasis. Patients were treated twice daily for 4 weeks with either Clobex® Lotion, 0.05% or vehicle lotion. After 4 weeks of treatment, success was achieved in 30 of 82 patients (36.6%) treated with Clobex® Lotion, 0.05% compared to 0 of 29 (0%) treated with vehicle, with success being defined as a score of none or very mild (no or very slight clinical signs or symptoms of erythema, plaque elevation, or scaling) on the Global Severity scale of psoriasis.

Two additional studies compared the use of Clobex® Lotion, 0.05% to cream preparations of clobetasol and vehicle lotion. The first was a single-blind, randomized, parallel-group study comparing Clobex® Lotion, 0.05% to Temovate® E Emollient cream, 0.05% in patients with moderate to severe plaque-type psoriasis.2 After 4 weeks of treatment, the success rate—defined as the proportion of 33 Clobex® (clobetasol propionate) Lotion, 0.05% patients with a global severity of none to mild—was 73.2% with Clobex® Lotion (60 of 82 subjects) versus 3.4% for vehicle lotion (1 of 29 subjects), a statistically significant difference. Clobex® Lotion was also shown to be non-inferior to Temovate® E emollient cream. Clobex® Lotion was extremely well tolerated in this study.

The second study compared Clobex® Lotion, 0.05% to Dermoval/Temovate cream, 0.05% and vehicle lotion in patients with moderate to severe plaque-type psoriasis.3 This study also followed a single-blind, randomized, parallel-group structure in multiple centers for 4 weeks. By the end of the study, significant reductions in the primary efficacy parameter of dermatological sum score (DSS) were observed for Clobex® Lotion (85%) and Dermoval/Temovate cream (80.8%) (Figure 7). Clobex® Lotion produced significantly greater reductions in DSS compared to its vehicle, and was not inferior to Dermoval/Temovate cream. Both active treatments were well tolerated.

Importantly for patients, a statistically significant difference favoring Clobex® Lotion compared to Dermoval/Temovate cream was observed for 5 items in a cosmetic acceptability questionnaire: satisfactory time of penetration, dried quickly, greasy sensation, pleasing aspect, and pleasing perfume.

Clobex® is not recommended for those under age 18.

See important efficacy, safety and prescribing information for Clobex® Spray and Clobex® Shampoo.

Temovate is a registered trademark of Altana.

References:

  1. Decroix J, Pres H, Tsankov N, Poncet M, Arsonnaud S. Clobetasol propionate lotion in the treatment of moderate to severe plaque-type psoriasis. Cutis. 2004;74:201-206.
  2. Clobex Lotion clinical trial U9707. Data on file. Manuscript in preparation. Galderma Laboratories.
  3. Clobex Lotion clinical trial 2651. Data on file. Manuscript in preparation. Galderma Laboratories.
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Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested. In controlled clinical trials, the following adverse reactions have been reported: burning, pruritus, dryness, pain, hyperpigmentation around resolving plaque, irritation and atrophy.

Clobex® (clobetasol propionate) Spray, 0.05% is not recommended for use on anyone younger than 18 years of age. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (59 mL or 2 fl oz) per week. Patients should use Clobex® (clobetasol propionate) Spray, 0.05%, only for the minimum period necessary to achieve desired results. Clobex® (clobetasol propionate) Spray, 0.05% should not be used on the face, groin, or axillae.

See full prescribing information for Clobex® Spray, Clobex® Lotion and Clobex® Shampoo.