Clobex® Spray, 0.05% is a clear, colorless liquid supplied in a white HDPE bottle with a white polypropylene cap and white LDPE liner in the following sizes: 2 fl oz/59 mL and 4.25 fl oz/125 mL
Active Ingredients:(clobetasol propionate) Spray, 0.05%
Indications and Usage:
Clobex® Spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.
Side Effects and Contraindications:
Adverse Reaction: In controlled clinical trials, the most common adverse reactions (> 2%) were burning, pruritus, nasopharyngitis and upper respiratory tract infection. Local adverse reactions may occur more frequently with the use of occlusive dressings.
Warnings and Precautions: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested. Treatment should be limited to 4 weeks.
The total dosage should not exceed 50 g (59 mL or 2 fl oz) per week. Do not use more than 26 sprays for each application or more than 52 sprays in 1 day.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA -1088.
Galderma Laboratories, L.P.
Clinical Pearls & Key Features:
- Class 1 strength that patients can count on for up to 4 weeks. 1,2,4
- Consistent efficacy in more than 2,000 patients with Clobex® Spray. 1-5
- An average of 80% of patients were clear or almost clear by week 4 in two pivotal Phase III trials (n=120).*1
- At week 1, 74% of patients showed improvement in Overall Disease Severity (ODS) by at least one grade. 6
- Clobex® Spray is formulated to easily penetrate the epidermis and dissolve quickly into the skin on the body and scalp. 7
* From 2 randomized, vehicle controlled clinical trials that were identically designed to assess the efficacy and safety of Clobex® Spray (n=120) or vehicle spray (n=120) in patients with moderate to severe psoriasis for up to 4 weeks. Patients were evaluated on their ODS.
1. Clobex® Spray Prescribing Information. September 2012. Galderma Laboratories, L.P.
2. Menter A. Topical monotherapy with clobetasol propionate spray, 0.05% in the COBRA trial. Cutis. 2007;80;12-19.
3. Sofen H, Hudson CP, Cook-Bolden FE , et al. Clobetasol propionate 0.05% spray for the management of moderate-to-severe plaque psoriasis of the scalp: results from a randomized controlled trial. J Drugs Dermatol. 2011;10:885-892.
4. Koo JY M. Relevance of the COBRA Trial in current psoriasis practice. Cutis. 2007;80(suppl 5):4-11.
5. Menter A, Abramovits W, Colón LE , Johnson LA , Gottschalk RW. Comparing clobetasol propionate 0.05% spray to calcipotriene 0.005% betamethasone dipropionate 0.064% ointment for the treatment of moderate to severe plaque psoriasis. J Drugs Dermatol. 2009;8:52-57.
6. Data on file. Galderma Laboratories, L.P.
7. Kircik LH, Bikowski JB , Cohen DE , Draelos ZC, Hebert A. Vehicles Matter: Clinical implications of delivery and application systems. Part 2 of 2. Practical Dermatol. 2010;(suppl):1-16.