General Information

Cabtreo is a combination of clindamycin phosphate (a lincosamide antibacterial), adapalene (a retinoid), and benzoyl peroxide.

Cabtreo is specifically indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.

Cabtreo is supplied as a topical ointment.

Dosing/Administration

Cleanse the affected area gently.

After the skin is dry, apply a thin layer of Cabtreo to the affected area once daily. Wash hands thoroughly after application.

Avoid the eyes, mouth, paranasal creases, mucous membranes, and areas of broken, eczematous, or sunburned skin.

Mechanism of Action

Clindamycin: Clindamycin is a lincosamide antibacterial.

Adapalene: Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.

Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action is unknown.

Clinical Trial Results

The FDA approval of Cabtreo was based on 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.