PMID- 26945741
OWN - NLM
STAT- MEDLINE
DCOM- 20170208
LR  - 20181113
IS  - 1179-1888 (Electronic)
IS  - 1175-0561 (Print)
IS  - 1175-0561 (Linking)
VI  - 17
IP  - 3
DP  - 2016 Jun
TI  - Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with 
      Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl 
      Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study.
PG  - 293-303
LID - 10.1007/s40257-016-0178-4 [doi]
AB  - BACKGROUND: A need exists for topical treatments in managing more severe 
      inflammatory acne. OBJECTIVES: The objectives of this study were to evaluate the 
      efficacy and safety of adapalene 0.3 %/benzoyl peroxide 2.5 % (0.3 % A/BPO) 
      topical gel in subjects with moderate and severe inflammatory acne. METHODS: This 
      was a multicenter, randomized, double-blind, parallel-group study. Randomization 
      was stratified by acne severity (50 % moderate and 50 % severe). Subjects 
      received 0.3 % A/BPO, 0.1 % A/BPO (benchmark), or vehicle (comparator) once daily 
      for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (the 
      percentage of subjects rated 'clear' or 'almost clear' with at least a 2-grade 
      improvement on Investigator's Global Assessment [IGA]) and change in inflammatory 
      (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary 
      efficacy endpoints were percent changes in IN and NIN lesion counts. Safety 
      endpoints were incidence of adverse events (AEs) and local tolerability 
      signs/symptoms. RESULTS: A total of 503 subjects were randomized: 217, 217, and 
      69 subjects in the 0.3 % A/BPO, 0.1 % A/BPO, and vehicle groups, respectively. 
      For success rate (subjects rated 'clear' or 'almost clear' with >/=2-grade 
      improvement in IGA), 0.3 % A/BPO was superior to vehicle, with a treatment 
      difference of 22.7 % (33.7 vs. 11.0 %; 95 % confidence interval [CI] 12.8-32.6, 
      p < 0.001). At week 12, 0.3 % A/BPO was superior to vehicle for mean reduction 
      from baseline in IN (27.0 vs. 14.4) and NIN lesion counts (40.2 vs. 18.5), as 
      well as for percentage reduction from baseline in IN (68.7 vs. 39.2 %) and NIN 
      lesion counts (68.3 vs. 37.4 %) (all p < 0.001). Among subjects with severe 
      inflammatory acne (IGA = 4), 0.1 % A/BPO did not reach statistical significance 
      for success rate compared with vehicle (p = 0.443), whereas 0.3 % A/BPO 
      demonstrated significantly greater efficacy (p = 0.029, requiring >/=3-point IGA 
      improvement). Additionally, 0.3 % A/BPO was safe and well-tolerated. CONCLUSIONS: 
      Results of this clinical trial demonstrate the significantly greater efficacy of 
      adapalene 0.3 % A/BPO topical gel compared with vehicle as well as a good safety 
      profile in the treatment of moderate to severe inflammatory non-nodulocystic 
      acne, which increases patients' treatment options. CLINICALTRIALS. GOV 
      IDENTIFIER: NCT01880320.
FAU - Stein Gold, Linda
AU  - Stein Gold L
AD  - Department of Dermatology, Henry Ford Medical Center, Detroit, MI, USA. 
      lstein1@hfhs.org.
AD  - Henry Ford Medical Group, 6530 Farmington Rd, West Bloomfield, MI, 48322, USA. 
      lstein1@hfhs.org.
FAU - Weiss, Jonathan
AU  - Weiss J
AD  - Gwinnett Clinical Research Center Inc., Snellville, GA, USA.
FAU - Rueda, Maria Jose
AU  - Rueda MJ
AD  - Galderma Laboratories LP, Fort Worth, TX, USA.
FAU - Liu, Hong
AU  - Liu H
AD  - Galderma Research and Development Inc., Princeton, NJ, USA.
FAU - Tanghetti, Emil
AU  - Tanghetti E
AD  - Center for Dermatology and Laser Surgery, Sacramento, CA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01880320
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - New Zealand
TA  - Am J Clin Dermatol
JT  - American journal of clinical dermatology
JID - 100895290
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Gels)
RN  - 0 (Naphthalenes)
RN  - 1L4806J2QF (Adapalene)
RN  - W9WZN9A0GM (Benzoyl Peroxide)
SB  - IM
MH  - Acne Vulgaris/*drug therapy
MH  - Adapalene/administration & dosage/adverse effects/*therapeutic use
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Benzoyl Peroxide/administration & dosage/adverse effects/*therapeutic use
MH  - Child
MH  - Dermatologic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Gels
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Naphthalenes
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC4863916
EDAT- 2016/03/08 06:00
MHDA- 2017/02/09 06:00
PMCR- 2016/03/05
CRDT- 2016/03/07 06:00
PHST- 2016/03/07 06:00 [entrez]
PHST- 2016/03/08 06:00 [pubmed]
PHST- 2017/02/09 06:00 [medline]
PHST- 2016/03/05 00:00 [pmc-release]
AID - 10.1007/s40257-016-0178-4 [pii]
AID - 178 [pii]
AID - 10.1007/s40257-016-0178-4 [doi]
PST - ppublish
SO  - Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.