Fixed‑Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Versus Adapalene 0.3%/Benzoyl Peroxide 2.5% Gels for Moderate‑to‑Severe Acne: Comparative Patient Journey

Background: The American Academy of Dermatology recommends combination treatment for most patients with acne, but adding ingredients to a treatment regimen may increase the risk of adverse effects. Clindamycin phosphate 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% (CAB) gel is the only triple-combination fixed-dose topical formulation for acne. In clinical studies, CAB gel demonstrated superior efficacy to vehicle and component dyad gels, with good safety/tolerability. Objectives: Document the treatment journey of clinical trial participants treated with either CAB gel or branded ADAP 0.3%/BPO 2.5% gel. Methods: In a phase 2, double-blind, 12-week study (NCT04892706), participants aged ≥12 years with moderate to severe acne were randomized to once-daily CAB, branded ADAP 0.3%/BPO 2.5% (ADAP/BPO), or vehicle gel. Assessments included treatment success (≥2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear skin), change from baseline in inflammatory (IL) and noninflammatory lesions (NIL), treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability. Descriptive data are summarized for 4 pairs of participants treated with CAB or ADAP/BPO; each pair was matched for baseline characteristics, acne severity, and lesion counts. Results: Participant ages ranged from 13-21 years. At week 12, 3 of 4 CAB-treated and 1 of 4 ADAP/BPO-treated participants achieved treatment success. IL reductions from baseline with CAB and ADAP/BPO ranged from 63.1%-100% and 40.6%-81.8% respectively. NIL reductions ranged from 55.8%-98.0% with CAB and 32.4%-94.3% with ADAP/BPO. One participant reported a treatment-related TEAE (CAB-treated; moderate stinging; resolved) and no serious treatment-related TEAEs were reported. Transient increases in cutaneous safety/tolerability resolved to or near baseline by week 12. Conclusions: In 4 matched participant pairs, treatment success and lesion reductions were greater overall with CAB gel than with ADAP/BPO gel, with similar safety/tolerability findings. In conjunction with results from the overall participant populations of CAB clinical trials, these data illustrate the potential of CAB gel as the only triple fixed-combination treatment option in the acne armamentarium. Funding: Ortho Dermatologics

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Publication Details

Journal
SKIN The Journal of Cutaneous Medicine
Published
2025-03-17
DOI
https://doi.org/10.25251/skin.10.supp.555
Primary Topic
Acne and Rosacea Treatments and Effects
Type
article
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article

Fixed‑Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Versus Adapalene 0.3%/Benzoyl Peroxide 2.5% Gels for Moderate‑to‑Severe Acne: Comparative Patient Journey

Eric Guenin, Edward Lain, Zoé Kececioglu Draelos, Julie Harper et al.
SKIN The Journal of Cutaneous Medicine
Acne and Rosacea Treatments and Effects
article

Fixed‑Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Versus Adapalene 0.3%/Benzoyl Peroxide 2.5% Gels for Moderate‑to‑Severe Acne: Comparative Patient Journey

Eric Guenin, Edward Lain, Zoé Kececioglu Draelos, Julie Harper, Lawrence Green, Leon Kircik, Keith J. Wroblewski, Lawrence F. Eichenfield, Hilary E. Baldwin, Neal Bhatia, William Philip Werschler
article en

Abstract

Background: The American Academy of Dermatology recommends combination treatment for most patients with acne, but adding ingredients to a treatment regimen may increase the risk of adverse effects. Clindamycin phosphate 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% (CAB) gel is the only triple-combination fixed-dose topical formulation for acne. In clinical studies, CAB gel demonstrated superior efficacy to vehicle and component dyad gels, with good safety/tolerability. Objectives: Document the treatment journey of clinical trial participants treated with either CAB gel or branded ADAP 0.3%/BPO 2.5% gel. Methods: In a phase 2, double-blind, 12-week study (NCT04892706), participants aged ≥12 years with moderate to severe acne were randomized to once-daily CAB, branded ADAP 0.3%/BPO 2.5% (ADAP/BPO), or vehicle gel. Assessments included treatment success (≥2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear skin), change from baseline in inflammatory (IL) and noninflammatory lesions (NIL), treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability. Descriptive data are summarized for 4 pairs of participants treated with CAB or ADAP/BPO; each pair was matched for baseline characteristics, acne severity, and lesion counts. Results: Participant ages ranged from 13-21 years. At week 12, 3 of 4 CAB-treated and 1 of 4 ADAP/BPO-treated participants achieved treatment success. IL reductions from baseline with CAB and ADAP/BPO ranged from 63.1%-100% and 40.6%-81.8% respectively. NIL reductions ranged from 55.8%-98.0% with CAB and 32.4%-94.3% with ADAP/BPO. One participant reported a treatment-related TEAE (CAB-treated; moderate stinging; resolved) and no serious treatment-related TEAEs were reported. Transient increases in cutaneous safety/tolerability resolved to or near baseline by week 12. Conclusions: In 4 matched participant pairs, treatment success and lesion reductions were greater overall with CAB gel than with ADAP/BPO gel, with similar safety/tolerability findings. In conjunction with results from the overall participant populations of CAB clinical trials, these data illustrate the potential of CAB gel as the only triple fixed-combination treatment option in the acne armamentarium. Funding: Ortho Dermatologics

SKIN The Journal of Cutaneous MedicineVol. 9(2)
Openalex Percentile: Top 90%
Acne and Rosacea Treatments and Effects
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