Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne in Children and Adolescents

Triple-Combination Clindamycin Phosphate Gel for Acne in Children and Adolescents

Overview

This gel combines clindamycin phosphate, adapalene, and benzoyl peroxide to treat moderate to severe acne in patients aged 12 and older. It’s the only approved fixed-dose combination for acne treatment.

Study Details

Data from two phase 3 studies involving children and adolescents with acne were analyzed. Participants aged 9 and older were given either the gel or a placebo for 12 weeks. Key goals included:

  • Successful treatment: at least a 2-point improvement in acne severity, with skin appearing clear or almost clear.
  • Reduction in both inflammatory and non-inflammatory acne lesions.
  • Tracking side effects and overall skin safety.

Results

At the end of 12 weeks:

  • 51.5% of adolescents using the gel showed treatment success, compared to 24.9% on the placebo (significant results).
  • Lesion reductions: 78.3% for inflammatory and 73.7% for non-inflammatory lesions with the gel, versus 50.5% and 42.9% for placebo (very significant results).
  • Most side effects were mild to moderate, with less than 2.5% stopping treatment due to side effects.
  • Among the few younger children in the study, all using the gel experienced success with significant reductions in lesions.

Conclusion

The studies suggest that the gel is a well-tolerated and effective option for treating acne in young patients, with many achieving significant improvement in just 12 weeks.

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