2025-10-29 09:00:13
Presenters: Draelos ZD,1 Baldwin H,2,3 Harper JC,4 Ghannoum M,5,6 Gold LS,7 Tanghetti EA,8 Guenin E,9 Kircik LH10-12
Affiliations: 1Dermatology Consulting Services, High Point, NC; 2The Acne Treatment and Research Center, Brooklyn, NY; 3Robert Wood Johnson University Hospital, New Brunswick, NJ; 4Dermatology & Skin Care Center of Birmingham, Birmingham, AL; 5Case Western Reserve University, Cleveland, OH; 6University Hospitals Cleveland Medical Center, Cleveland, OH; 7Henry Ford Hospital, Detroit, MI; 8Center for Dermatology and Laser Surgery, Sacramento, CA; 9Ortho Dermatologics,* Bridgewater, NJ; 10Icahn School of Medicine at Mount Sinai, New York, NY; 11Indiana University School of Medicine, Indianapolis, IN; 12Physicians Skin Care, DermResearch, and Skin Sciences, Louisville, KY
Background: Acne treatment may take months to years in some cases due to the chronic nature of the condition. Even after lesions are cleared, acne sequelae, such as scarring and dyspigmentation, may remain, and can be more distressing to patients than the acne itself. Clindamycin phosphate 1.2%/ adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only approved triple-combination topical acne treatment. CAB gel demonstrated superior efficacy to vehicle and its component dyads and a favorable safety and tolerability profile in 12-week phase 2 and phase 3 clinical trials of moderate to severe acne.
Objective: The long-term efficacy and tolerability of CAB gel and its impacts on acne scarring and dyspigmentation were evaluated in this pooled analysis.
Methods: Data were pooled from two identical, 24-week, single-center, open-label studies of once-daily CAB gel in 50 participants ≥12 years with moderate or severe acne (Investigator’s Global Assessment [IGA] score=3 or 4) to evaluate changes from baseline in IGA score and inflammatory and noninflammatory lesions. Investigator-assessed skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]) and participant-assessed tolerability (itching, burning, redness, swelling) were evaluated on a 5-point scale (0 [none] to 4 [severe]). Scarring was assessed using the Goodman Qualitative Scar Scale. Adverse events were also assessed.
Results: Of 50 participants enrolled, 45 completed the studies. The mean age was 22 years, 76% were female, and all Fitzpatrick skin types were represented. At week 24, 67% of participants achieved treatment success, which was defined as a ≥2-grade reduction in IGA score from baseline and clear/ almost clear skin. Additionally, significant reductions in inflammatory lesions (88%) and noninflammatory lesions (68%) were observed (P<0.001 vs baseline, both). At week 24, PIH improved by 71%, PIE decreased by 77%, and scarring severity was reduced by 33% from baseline (P<0.001, all). Mean scores for skin dryness remained low (<0.15). Most participants (>70%) reported no tolerability issues across all time points. A total of 7 adverse events occurred during the studies; 4 were related to study product, and 3 led to study discontinuation.
Conclusion: In this pooled analysis, CAB gel treatment resulted in significant and continued improvements in acne lesions, scarring, and dyspigmentation over 6 months of once-daily use. Further, CAB gel was well tolerated and no new safety or tolerability signals were observed. These results support the long-term use of CAB gel as a topical acne treatment.
Disclosures: Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC. ZDD received funding from Ortho Dermatologics. HB has served as an advisor, as an investigator, and on speakers’ bureaus for Almirall, Cassiopea, Foamix, Galderma, Ortho Dermatologics, Sol Gel, and Sun Pharma. JCH has received honoraria from Almirall, Cutera, Galderma, LaRoche-Posay, Ortho Dermatologics, and Sun Pharma. MG has acted as a consultant or received contracts from Scynexis, Inc., Bausch & Lomb, Pfizer, and Mycovia. LSG has served as an investigator/ consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis, and Lilly. EAT has served as speaker for Novartis, Ortho Dermatologics, Sun Pharma, Lilly, Galderma, AbbVie, and Dermira; served as a consultant/on clinical studies for Hologic, Ortho Dermatologics, and Galderma; and is a stockholder for Accure. EG is an employee of Ortho Dermatologics and may hold stock and/ or stock options in its parent company. LHK has served as either a consultant, speaker, advisor, or investigator for Allergan, Almirall, EPI Health, Galderma, Novartis, Ortho Dermatologics, and Sun Pharma.
Funding: Funding provided by Ortho Dermatologics.
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