2025-10-31 14:14:26
Presenters: Ghannoum M,1,2 Eltokhy A,1 Sewake J,1 McCormick T,1 Bhatia N,3 Baldwin, H,4,5 Gold LS,6 Harper JC,7 Zeichner JA,8 Lain E,9 Callender VD,10,11 Guenin E,12 Draelos ZD13
Affiliations: 1Case Western Reserve University, School of Medicine, Cleveland, OH; 2University Hospitals Cleveland Medical Center, Cleveland, OH; 3Therapeutics Clinical Research, San Diego, CA; 4The Acne Treatment and Research Center, Brooklyn, NY; 5Robert Wood Johnson University Hospital, New Brunswick, NJ; 6Henry Ford Hospital, Detroit, MI; 7Dermatology & Skin Care Center of Birmingham, Birmingham, AL; 8Icahn School of Medicine at Mount Sinai, New York, NY; 9Austin Institute for Clinical Research, Austin, TX; 10Callender Dermatology and Cosmetic Center, Glenn Dale, MD; 11Howard University College of Medicine, Washington, DC; 12Ortho Dermatologics,* Bridgewater, NJ; 13Dermatology Consulting Services, High Point, NC
Background: The only approved triplecombination acne treatment, clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel, demonstrated superior efficacy to vehicle with favorable safety/tolerability in 12-week phase 2 and phase 3 trials of moderate to severe acne. However, acne treatment in the real world may require 6 months for maximum benefits in some cases. One concern with long-term antibiotic use is the development of antibiotic resistance in the causative bacterium Cutibacterium acnes (C. acnes).
Objective: The objective of this analysis was to evaluate the effect of long-term CAB use on C. acnes strains, including clindamycin susceptibility.
Methods: Two identical, 24-week, single-center, open-label studies evaluated once-daily CAB in participants ≥12 years with moderate or severe acne (Investigator’s Global Assessment [IGA] of 3 or 4); pooled data from these studies were analyzed. Plates inoculated with central forehead swabs collected from study participants at baseline and week 24 were monitored for C. acnes colony formation. Clindamycin susceptibility was assessed via minimum inhibitory concentration (MIC) values using Epsilometer tests; MIC ≥8 μg/mL indicated resistance.
Results: Of 50 participants enrolled, 45 completed the studies. At baseline, C. acnes strains were isolated from 82% (37/45) of participants. Following 24 weeks of CAB treatment, participants with cultivable isolates were reduced by nearly half to 44% (20/45). MIC values remained low (mean: 0.19 μg/mL) for clindamycin-susceptible strains isolated at week 24. Only 1 participant without any bacterial growth at baseline had cultivable C. acnes at week 24; this isolate was deemed clindamycin susceptible. There was no change from baseline in clindamycin-resistant isolates; only the 5 participants (11%) with resistant C. acnes isolates at baseline also had resistant isolates at study end. Notably, all 5 of these participants had acne improvements at week 24 (IGA decrease, 1-3 points; lesion reductions, 40%-100%).
Conclusion: In these 24-week studies, CAB gel did not lead to the development of antibiotic resistance and was efficacious in participants with clindamycin-resistant C. acnes isolates at baseline. Further, CAB treatment resulted in an almost 50% reduction from baseline in participants with cultivable C. acnes isolates, demonstrating elimination of C. acnes strains. Taken together with previously published efficacy analyses, these data suggest CAB gel is well suited to long-term acne treatment.
Disclosures: Ortho Dermatologics is a division of Bausch Health US, LLC. MG has acted as a consultant or received contracts from Scynexis, Inc, Bausch & Lomb, Pfizer, and Mycovia. NB has served as advisor, consultant, and investigator for AbbVie, Almirall, Biofrontera, BI, Brickell, BMS, EPI Health, Ferndale, Galderma, InCyte, ISDIN, J&J, LaRoche-Posay, LEO Pharma, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma, Verrica, and Vyne. HB has served as advisor, as investigator, and on speakers bureaus for Almirall, Cassiopea, Foamix, Galderma, Ortho Dermatologics, Sol Gel, and Sun Pharma. Linda Stein Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis, and Lilly. JCH has received honoraria from Almirall, Cutera, Galderma, LaRoche- Posay, Ortho Dermatologics, and Sun Pharma. Joshua A. Zeichner has served as advisor, consultant, or speaker for AbbVie, Allergan, Dermavant, Dermira, EPI Health, Galderma, Incyte, Johnson and Johnson, L'Oreal, Ortho Dermatologics, Pfizer, Procter and Gamble, Regeneron, Sun Pharma, UCB, Unilever, and Vyne. EL has served as investigator, consultant and/or speaker for Ortho Dermatologics, AbbVie, Almirall, Amgen, Arcutis, Dermavant, EPI Health, Galderma, Incyte, LEO Pharma, Novartis, Eli Lilly, Pfizer, Sun Pharma, UCB, Endo International, ChemoCentryx, Biorasi, Sirnaomics, Evelo Biosciences, Concert Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Mindera, Biofrontera, Alfasigma, AiViva Biopharma, Anaptys Bio, Bausch Health, Dr Reddy’s, and Trevi Therapeutics. VDC has served as an investigator, consultant, or speaker for Acne Store, Almirall, Aerolase, AbbVie, Allergan Aesthetics, Avava, Avita Medical, Beiersdorf, Cutera, Dermavant, Eirion Therapeutics, Eli Lilly, Galderma, Janssen, Jeune Aesthetics, L’Oréal, Ortho Dermatologics, Pfizer, Prollineum, Regeneron, Scientis, Sente, SkinBetter Science, SkinCeuticals, Symatese, Teoxane, and UpToDate. EG is an employee of Ortho Dermatologics and may hold stock and/ or stock options in its parent company. ZDD received funding from Ortho Dermatologics to conduct the research presented in this poster. The remaining authors have nothing to disclose.
Funding: Funding provided by Ortho Dermatologics.
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