A recent study presented at the 2024 Elevate-Derm West Conference in Scottsdale, Arizona, highlights the efficacy and safety of fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel in treating Hispanic patients with moderate to severe acne. The research indicates a significant improvement in treatment success rates compared to vehicle gel, offering a promising option for this demographic.
Study Design and Methods
The analysis included 147 self-identified Hispanic participants from a phase 2 (NCT03170388) and two phase 3 (NCT04214652 and NCT04214639) randomized, double-blind, 12-week studies. The primary endpoint was the proportion of participants achieving "treatment success," defined as at least a 2-grade reduction in the Evaluator’s Global Severity Score (EGSS) and a final score of "clear" or "almost clear" skin. Researchers also assessed changes in inflammatory and non-inflammatory lesion counts and monitored safety through cutaneous adverse events.
Significant Improvement in Treatment Success
Results showed that 56.2% of Hispanic participants treated with CAB gel achieved treatment success by week 12, compared to only 18.4% in the vehicle group (P<0.001). The average age of participants was approximately 20 years, with a mix of male and female subjects, predominantly classified as White-Hispanic. Baseline lesion counts and severity scores were comparable across both treatment groups.
Reduction in Lesion Counts
By the end of the study, inflammatory lesion counts were reduced by 75%, and non-inflammatory lesion counts saw a reduction of 57.8% with CAB gel, demonstrating marked improvements over the vehicle. Reductions in both inflammatory and non-inflammatory lesions with CAB gel were statistically significant from week 4 through week 12 compared to the vehicle group.
Safety Profile
The majority of adverse events reported were mild to moderate, with a low incidence of severe events. Common adverse events included application site reactions such as dryness, itching, and burning, which decreased over time and were manageable.
Clinical Implications for Diverse Populations
"These results, combined with those of previous post hoc analyses in self-identified Black study participants, demonstrated that CAB is an efficacious, safe, and tolerable acne treatment for patients of different racial and ethnic backgrounds," the researchers wrote. Given the limited data on acne treatments specific to Hispanic populations, this analysis offers valuable insights into the benefits of CAB gel for this demographic. Clinicians treating diverse patient populations can consider CAB gel as a safe and effective option for achieving better skin outcomes in patients with acne.
