FDA Approves Cabtreo(TM) (Clindamycin Phosphate, Adapalene and Benzoyl Peroxide) Topical Gel for the Treatment of Acne Vulgaris in Patients Twelve Years of Age and Older - Seite 2

Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and approximately 75% reduction in both inflammatory and noninflammatory lesions at Week 12.

In Study 1, 49.6% of participants achieved treatment success with CABTREO compared to 24.9% with vehicle. Mean percent reduction for inflammatory lesions was 75.7% (27.7 mean absolute reduction) vs. 59.6% (21.7 mean absolute reduction) with vehicle. Mean percent reduction for non-inflammatory lesions was 72.7% (35.4 mean absolute reduction) vs. 47.6% (23.5 mean absolute reduction) with vehicle.

In Study 2, 50.5% of participants achieved treatment success with CABTREO compared to 20.5% with vehicle. Mean percent reduction for inflammatory lesions was 80.1% (30.1 mean absolute reduction) vs. 56.2% (20.8 mean absolute reduction) with vehicle. Mean percent reduction for non-inflammatory lesions was 73.3% (35.2 mean absolute reduction) vs. 49.0% (22.0 mean absolute reduction) with vehicle.

The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis.

About Acne Vulgaris

Acne is the most common skin problem in the United States, which occurs when hair follicles become obstructed with sebum and skin cells, resulting in the formation of whiteheads, blackheads, or pimples on the face, forehead, chest, upper back and shoulders.^1,2 Up to 50 million Americans have acne.² Depending on its severity, acne can cause emotional distress and scar the skin.²

What is CABTREO?

CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% is a prescription medicine used on the skin only (topical use) to treat acne vulgaris in adults and children 12 years of age and older. Do not use CABTREO in your mouth, eyes, or vagina.

IMPORTANT SAFETY INFORMATION

Before using CABTREO, tell your healthcare provider about all your medical conditions, including if you: plan to have surgery, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed, have other skin problems, including cuts, abrasions, sunburn, or eczema; or use other skin and topical acne products that may increase the irritation of your skin when used with CABTREO.