Adapalene 0.3% / benzoyl peroxide 2.5% gel plus oral doxycycline is an effective and safe option for oral isotretinoin candidates with severe inflammatory acne (non-nodulocystic/nonconglobate)
Presenters: Del Rosso J1, Gold LS2, Johnson SM3, Rueda MJ4, Baldwin H5, Lain EL6, Landis M7, Rendon M8, Tanghetti E9, Thiboutot D10, Weiss J11
Affiliations: 1Thomas Dermatology, Las Vegas, N; 2Henry Ford Medical Center, Deptartment of Dermatology, Detroit, MI; 3Johnson Dermatology, Fort Smith, AR; 4Galderma Laboratories, L.P., Fort Worth, TX; 5The Acne Treatment and Research Center, Morristown, NJ; 6Austin Institute for Clinical Research, Pflugerville, TX; 7Forefront Dermatology, Jeffersonville, IN; 8Rendon Center for Dermatology and Aesthetic Medicine, Boca Raton, FL; 9Center for Dermatology and Laser Surgery, Sacramento, CA; 10The Pennsylvania State University College of Medicine, Hershey, PA; 11Gwinnett Dermatology, Snellville, GA
Background/Objective: Acne treatment guidelines suggest combined topical therapy with oral antibiotics or oral isotretinoin (OI) as first-line treatments for severe acne. This study tested the efficacy and safety of a daily regimen of 0.3% adapalene/benzoyl peroxide (ABPO) gel and oral doxycycline 200mg (DOX, two 50mg delayed-release tablets twice-daily) in severe (non-nodulocystic, nonconglobate) inflammatory acne.
Methods: This was a Phase IV, 12-week, single-arm, open-label, multicenter investigational study. Men and women aged 12 years or older with severe inflammatory acne (IGA 4, n=186) and considered OI candidates by the investigator were enrolled. OI candidacy was reevaluated at each study visit. Efficacy endpoints included inflammatory lesion (IL) reduction (Week 12), IGA success (Weeks 4, 8, and 12), percent-reduction in lesions (Weeks 4, 8, and 12), and subject questionnaires (Week 12). Safety assessments included adverse events (AEs) and tolerability.
Results: Mean IL counts were significantly reduced (standard deviation [SD]; baseline, 44.8 (21.73); Week 12, 14.8 (16.11); mean percent-reduction, 66.2% [30.47]; P<.0001). By Week 12, 37.1 percent of subjects achieved IGA Success (n=69, P<0.0001). Most subjects self-reported at least moderate improvement in acne (90.2%) and were “Satisfied” or “Very Satisfied” with the study treatment overall (83.2%). Nearly half (41.9%) of the subjects were no longer considered OI candidates at Week 4. At 12 weeks, just 19.9 percent were still considered OI candidates. Twenty-seven (15.4%) AE were considered to have a reasonable possibility of being treatment-related (gastrointestinal disorders were the most common; n=7, 4.0%). Only four subjects discontinued due to an adverse event, (“skin burning sensation”; 1 mild, 2 moderate, 1 severe; all were considered “possibly related”).
Conclusion: 0.3% A/BPO plus DOX is an effective and safe treatment option for severe inflammatory acne (non-nodulocystic, nonconglobate) before starting OI treatment or as an alternative when OI cannot be used.
Funding/disclosures: This study was sponsored by Galderma Laboratories, L.P. Galderma is the maker of Epiduo Forte Gel. Dr. Rueda is an employee of Galderma. All other authors are advisors or investigators for Galderma.