The only FDA-approved fixed-dose triple-combination acne therapy has demonstrated significant efficacy and safety in Hispanic patients, according to a recent post-hoc analysis. The same treatment also showed promising long-term results in a separate 24-week trial, expanding its potential as a durable treatment option for diverse patient populations with moderate to severe acne.
Triple-Combination Therapy Shows Strong Results in Hispanic Patients
A post-hoc analysis of data from phase 2 and phase 3 clinical trials has revealed that a fixed-dose combination gel containing clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1% (CAB) is both effective and well-tolerated in Hispanic patients with moderate to severe acne.
The analysis included 147 self-identified Hispanic or Latino patients from previous double-blind, vehicle-controlled, randomized studies. Participants were randomized to receive either CAB (n=90) or vehicle cream (n=57) once daily for 12 weeks, along with a supportive skincare regimen including hydrating cleanser, moisturizing lotion, and sunscreen.
By week 12, over 56% of Hispanic patients using CAB achieved treatment success—defined as a ≥2-grade reduction from baseline on the Evaluator's Global Severity Score (EGSS) and clear or almost clear skin—compared to just 18.4% in the vehicle group (p<0.001). Notably, improvements were observed as early as week 2.
The CAB-treated group experienced more than 75% reductions in both inflammatory and noninflammatory lesions by the end of the 12-week period, significantly outperforming the approximately 50% decrease seen in the vehicle group.
"These improvements with CAB are notable, as some racial and ethnic groups may experience greater deficits in daily functioning and quality of life owing to acne symptoms," the study authors noted.
Quality of life measures also showed significant improvement. Patients treated with CAB reported greater enhancements in Acne-Specific Quality of Life (Acne-QoL) scores versus those receiving vehicle, particularly in the domains of self-perception, role-social, and role-emotional. Additionally, baseline hyperpigmentation scores decreased from 0.6 to 0.3 after 12 weeks of CAB treatment.
The safety profile was favorable, with most adverse events being mild to moderate. The most commonly reported issues were pain and pruritus at the application site. Some transient increases in scaling, itching, burning, and stinging occurred at week 2 but returned to normal by week 8, and no serious adverse effects were reported.
Long-Term Efficacy and Safety Confirmed in 24-Week Study
Complementing these findings, Dr. Zoe Diana Draelos presented results from a 24-week, single-center, open-label trial at the 2025 Music City Symposium for Cosmetic Advances and Laser Education (SCALE) Conference in Nashville, Tennessee.
This study evaluated the long-term safety and efficacy of the CAB gel in 25 participants aged 12 years and older with moderate to severe acne. The study population had a mean age of 23.9 years, was approximately 80% female, and represented diverse skin types, with over 55% having Fitzpatrick skin types V-VI.
After 24 weeks of once-daily application, 68% of patients achieved treatment success. Significant reductions in Investigator's Global Assessment (IGA) scores were observed from week 4 through week 24 (p<0.001). Lesion counts decreased substantially, with noninflammatory lesions reduced by 70% and inflammatory lesions by an impressive 89% by the end of the trial.
"CAB gel is an appropriate and effective option for the long-term treatment of acne vulgaris," Dr. Draelos told Dermatology Times.
Beyond acne clearance, the study documented improvements in acne sequelae. Facial scarring improved by 33% at week 24, with initial improvements noted at week 12. Postinflammatory hyperpigmentation was reduced by 77% and postinflammatory erythema by 84%, with early results observed as early as week 4.
The long-term safety profile remained consistent with earlier findings. No adverse events or tolerability issues were reported, with minimal scores for swelling, itching, redness, and burning throughout the treatment period.
Significance for Diverse Patient Populations
These findings are particularly significant for patients with skin of color, who are more likely to experience postinflammatory hyperpigmentation and irritation from acne and its treatments. The CAB gel's demonstrated efficacy and safety in Hispanic patients mirrors results from a separate post-hoc analysis involving Black participants, suggesting consistent performance across diverse ethnic groups.
The triple-combination approach addresses multiple pathophysiological factors in acne development. Clindamycin phosphate provides antimicrobial activity, adapalene normalizes follicular keratinization, and benzoyl peroxide delivers additional antimicrobial effects while helping prevent antibiotic resistance.
As the only FDA-approved fixed-dose triple-combination therapy for acne, the CAB gel offers a simplified treatment regimen that may enhance patient adherence while effectively targeting multiple aspects of acne pathogenesis.
These studies collectively support the use of this triple-combination therapy as an effective and well-tolerated option for diverse patient populations with moderate to severe acne, with benefits extending beyond lesion reduction to improvements in scarring, dyspigmentation, and quality of life.
