Triple-combination gel treatment for acne demonstrates efficacy, safety across age groups
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Key takeaways:
- 52.7% of pediatric patients treated with the triple-combination gel vs. 24% of vehicle-treated patients achieved treatment success.
- Similar results were seen among adult patients (45.9% vs. 23.5%, respectively).
Fixed-dose clindamycin phosphate 1.2%, adapalene 0.15% and benzoyl peroxide 3.1% gel demonstrated safety and efficacy across all age groups for the treatment of acne, according to a post hoc analysis.
“Although acne affects patients of all ages, there are age-related differences in clinical presentation as well as patients’ experience with acne and acne treatments,” Hilary E. Baldwin, MD, medical director at the Acne Treatment & Research Center and clinical associate professor at Rutgers Robert Wood Johnson Medical Center, and colleagues wrote. “Acne onset typically corresponds to hormonal changes during puberty, and shifts toward earlier puberty are associated with increasing acne prevalence among preteen children.”
Clindamycin phosphate 1.2%, adapalene 0.15% and benzoyl peroxide 3.1% gel (CAB) is the first fixed-dose triple-combination FDA approved for the treatment of acne. In this post hoc analysis of two double-blind, phase 3 studies, researchers assessed the efficacy and safety of fixed-dose CAB in both pediatric and adult patients.
In the trials, 363 patients aged 9 years and older with moderate to severe acne received either once-daily CAB gel or vehicle for 12 weeks. Results showed that those treated with CAB vs. vehicle had significantly better outcomes in both the pediatric and adult cohorts.
By week 12, 52.7% of pediatric patients treated with CAB vs. 24% of vehicle-treated patients achieved treatment success, which was defined as achieving a 2 or higher-grade reduction from baseline and a clear or almost clear score in Evaluator’s Global Severity Score (P < .01). Similarly, 45.9% of adult patients treated with CAB vs. 23.5% of vehicle-treated adults achieved the same (P < .01).
CAB-treated vs. vehicle-treated patients saw greater reductions from baseline in inflammatory lesions in both the pediatric (78.6% vs. 50.4%) and adult cohorts (76.6% vs. 62.8%; P < .001 for both). Similar findings were seen for noninflammatory lesions as well compared in pediatric patients (73.8% vs. 41.1%) and adults (70.7% vs. 52.2%; P < .001 for both).
By week 12, quality of life improvements were also significantly higher among CAB-treated patients vs. vehicle-treated patients. Mean increases from baseline in all acne quality of life scores with CAB treatment ranged from 3.3 to 6.1 for participants aged 18 years and younger and 7.3 to 11.9 in those who aged older than 18 years. In contrast, vehicle-treated patients saw mean quality of life improvements of 1.9 to 4.1 and 4.6 to 6.7 in the respective age groups.
Safety results showed that most treatment-emergent adverse events were of mild to moderate severity and did not follow any age-related trends.
“The favorable safety and efficacy profile of CAB demonstrates its potential as an effective option for the treatment of acne in patients of all ages,” the authors concluded.