The FDA has approved the first and only fixed-dose, triple-combination topical treatment for acne. Cabtreo™ (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% from Ortho Dermatologics is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Cabtreo offers three mechanisms of action, combining an antibiotic, retinoid and antibacterial, to provide a proven, safe and effective treatment. Two Phase 3 multicenter, randomized, placebo controlled clinical trials involving 363 patients with acne vulgaris met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving treatment success (2 grade reduction of the EGSS (evaluators global severity score) from baseline with an EGSS score of clear (0) or almost clear (1)).
Combined efficacy results for both trials show that Cabtreo achieved approximately 50% treatment success and approximately 75% reduction in both inflammatory and noninflammatory lesions at Week 12.
Ortho Dermatologics expects Cabtreo to be available to patients in the first quarter of 2024.
“We are excited to see that the triple combination in Cabtreo has resulted in significant treatment success and reduction in both the inflammatory and noninflammatory lesions typically associated with acne,” said Julie C. Harper, MD, of Dermatology & Skin Care Center of Birmingham in Birmingham, AL. “With the approval of Cabtreo, physicians can now offer patients an acne treatment that has the potential to be a simple, once daily dosing option.”
In clinical trials, 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.