PMID- 29537444 OWN - NLM STAT- MEDLINE DCOM- 20180905 LR - 20180905 IS - 1545-9616 (Print) IS - 1545-9616 (Linking) VI - 17 IP - 3 DP - 2018 Mar 1 TI - Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Oral Doxycycline in Subjects With Severe Inflammatory Acne Who Are Candidates for Oral Isotretinoin. PG - 264-273 AB - INTRODUCTION: Acne treatment guidelines suggest a combination approach with topical therapy including a topical retinoid, benzoyl peroxide and an oral antibiotic, or oral isotretinoin (OI), as first-line treatment options for severe acne vulgaris (AV). This study evaluated the efficacy and safety of a daily regimen of 0.3% adapalene and 2.5% benzoyl peroxide (0.3% A/BPO) gel and oral doxycycline 100 mg twice daily in severe (nonnodulocystic, non-conglobate) inflammatory AV. METHODS: This was a phase 4, 12-week, single-arm, openlabel, multi-center investigational study. Subjects (males and females, 12 or older, with severe inflammatory AV, Investigator Global Assessment [IGA] 4, and less than equal to 4 nodulocystic lesions, n=186) were considered OI candidates at baseline by the investigator. OI candidacy was re-evaluated at each study visit. Efficacy endpoints included inflammatory lesion (IL) reduction (week 12), IGA success (defined as IGA 0 [Clear] or 1 [Almost Clear], 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 from baseline to the end of the study (mean [SD]; baseline, 44.8 (21.73); week 12, 14.8 (16.11); mean percent reduction, 66.2% [30.47]; P less than .0001). By week 12, 37.1% of subjects achieved IGA Success (n=69, P less than .0001). Most subjects self-reported at least moderate improvement in AV (90.2%), and were "Satisfied" or "Very Satisfied" with the study treatment overall (83.2%). 41.9% of the subjects were no longer considered by their investigator to be OI candidates at week 4. At 12 weeks, only 19.9% were still considered OI candidates. CONCLUSION: 0.3% A/BPO + DOX is an effective and safe treatment option for severe inflammatory AV, before starting OI treatment, or as an alternative when OI cannot be used. ClinicalTrials.gov identifier: NCT02899000

J Drugs Dermatol. 2018;17(3):264-273.

. FAU - Del Rosso, James Q AU - Del Rosso JQ FAU - Stein Gold, Linda AU - Stein Gold L FAU - Johnson, Sandra Marchese AU - Johnson SM FAU - Rueda, Maria Jose AU - Rueda MJ FAU - Baldwin, Hilary AU - Baldwin H FAU - Lain, Edward L AU - Lain EL FAU - Landis, Megan AU - Landis M FAU - Rendon, Marta AU - Rendon M FAU - Tanghetti, Emil AU - Tanghetti E FAU - Weiss, Jonathan AU - Weiss J LA - eng SI - ClinicalTrials.gov/NCT02899000 PT - Clinical Trial, Phase IV PT - Journal Article PT - Multicenter Study PL - United States TA - J Drugs Dermatol JT - Journal of drugs in dermatology : JDD JID - 101160020 RN - 0 (Dermatologic Agents) RN - 0 (Gels) RN - 1L4806J2QF (Adapalene) RN - EH28UP18IF (Isotretinoin) RN - N12000U13O (Doxycycline) RN - W9WZN9A0GM (Benzoyl Peroxide) SB - IM MH - Acne Vulgaris/diagnosis/*drug therapy MH - Adapalene/*administration & dosage MH - Administration, Oral MH - Adolescent MH - Adult MH - Benzoyl Peroxide/*administration & dosage MH - Child MH - Dermatologic Agents/*administration & dosage MH - Doxycycline/*administration & dosage MH - Drug Compounding MH - Female MH - Gels MH - Humans MH - Isotretinoin/*administration & dosage MH - Male MH - Severity of Illness Index MH - Treatment Outcome MH - Young Adult EDAT- 2018/03/15 06:00 MHDA- 2018/09/06 06:00 CRDT- 2018/03/15 06:00 PHST- 2018/03/15 06:00 [entrez] PHST- 2018/03/15 06:00 [pubmed] PHST- 2018/09/06 06:00 [medline] AID - S1545961618P0264X [pii] PST - ppublish SO - J Drugs Dermatol. 2018 Mar 1;17(3):264-273.