Cabtreo is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne.

The U.S. Food and Drug Administration (FDA) has approved CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel for the topical treatment of acne vulgaris in patients aged 12 and older. 

Bausch Health and Ortho Dermatologics' CABTREO is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne. It combines an antibiotic, retinoid, and antibacterial. CABTREO is expected to be available to patients in early 2024.

"This is a game changer in efficacy for the topical therapy of acne," says Christopher Bunick, MD, PhD, Practical Dermatology advisory board member and associate professor of dermatology and physician-scientist at the Yale School of Medicine in New Haven, Connecticut. 

"While most acne treatments currently available utilize multiple therapies and regimens, 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," says Julie C. Harper, MD., Dermatology & Skin Care Center of Birmingham, Birmingham, AL, in a news release.  "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."

CABTREO was studied in two Phase 3 multicenter, randomized, placebo-controlled clinical trials in 363 patients with acne vulgaris. Both studies 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 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.

CABREO's innovative formulation is one of the product's key advancements. Created with a unique polymetric mesh, the topical gel ingredients synergize in a brand new way, according to Dr. Bunick. "The long-awaited molecule known as IDP-126 has a name, CABTREO. It is the first 3-ingredient acne product at fixed doses to be approved," he says.

"With today's approval of CABTREO, millions of Americans who suffer from acne each year have a new triple-combination topical acne treatment," adds Thomas J. Appio, Chief Executive Officer, Bausch Health. "Acne treatment often requires using multiple products and dosing regimens, which can pose a number of challenges for patients. CABTREO has the potential to simplify dosing with a once daily topical acne treatment regimen."

Acne Experts React to Approval of Cabtreo

This approval is a big deal for acne patients and doctors who treat them, says Joshua Zeichner, MD, an associate professor and director of Cosmetic and Clinical Research at the Mount Sinai Hospital in New York City.

"The approval of CABTREO finally brings dermatologists the triple threat we have been waiting for to treat acne," he says. "The drug delivers three of the most commonly used actives in a single product."

This not only provides an effective treatment that addresses multiple pathogenic factors at the same time, but also significantly improves adherence to the regimen with once a day dosing, he says. "Ultimately, this means better outcomes for our patients."

Emmy M. Graber, MD, MBA, the founder of the Dermatology Institute of Boston and member of the Board of Directors at The American Acne and Rosacea Society, agrees. 

“Its three-in-one formula will make it convenient to prescribe, convenient to use, and efficacious,” says Graber, director of the Acne and Rosacea Meeting (Arm) series.“We can get the action of a benzoyl peroxide, a topical antibiotic, and a topical Retinoid, all with one prescription, eliminating the hassle of both prescribing multiple products, and reducing the burden on our patients of using multiple different products.”

The discovery of a regimen that's easy to follow is a boon for families with kids diagnosed with acne vulgaris. Sandra Lee, MD, board-certified dermatologist and Mohs surgeon at Skin Physicians & Surgeons in Upland, California (also known as Dr. Pimple Popper) says the daily treatment is "fantastic for busy kids."

Any barriers to compliance can hinder recovery, so CABTREO's simple protocol is a welcome advancement for adolescents. "They don't have time and don't want to be bothered. It's convenient and easy for anyone to use," says Lee.

Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research and chief medical editor for Practical Dermatology agrees that Cabtreo's ability to be used by patients as young as 12 can make a huge difference in an entire family's quality of life. "Just think how many happy parents there will be that their child only needs one product," he says.