PMID- 26659936
OWN - NLM
STAT- MEDLINE
DCOM- 20160919
LR  - 20151215
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 14
IP  - 12
DP  - 2015 Dec
TI  - Customized Single-agent Therapy Management of Severe Inflammatory Acne: A 
      Randomized, Double-blind, Parallel-group, Controlled Study of a New 
      Treatment--Adapalene 0.3%-Benzoyl Peroxide 2.5% Gel.
PG  - 1427-35
AB  - BACKGROUND: More effective therapies are needed in the specific treatment of 
      severe inflammatory acne vulgaris. OBJECTIVES: To demonstrate superior efficacy 
      of adapalene 0.3%-benzoyl peroxide 2.5% gel (0.3% A/BPO) vs. vehicle, and to 
      assess efficacy of 0.3% A/BPO vs. 0.1% A/BPO in subjects with severe inflammatory 
      acne (Investigator's Global Assessment [IGA] of 4) in the context of a larger 
      trial in a moderate and severe population. METHODS: This was a multicenter, 
      randomized, double-blind, parallel-group, 12-week study. Subjects were randomized 
      to receive 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 
      (percentage of subjects rated "clear" or "almost clear," >/= 3-grade IGA 
      improvement), 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: In the severe 
      inflammatory acne population, a total of 252 subjects were randomized with 106, 
      112 and 34 subjects in the 0.3% A/BPO, 0.1% A/BPO and vehicle groups, 
      respectively, reaching a high rate of study completion (88.5%). At week 12, both 
      0.3% A/BPO and 0.1% A/BPO were superior to vehicle in terms of lesion count 
      reduction. However for success rate, only 0.3% A/BPO achieved significantly 
      greater efficacy over vehicle with a treatment difference of 20.1% (31.9% vs. 
      11.8%; 95% Confidence Interval (CI): [6.0%, 34.2%], P=.029), whereas 0.1% A/BPO 
      did not (treatment difference vs. vehicle of 8.8%; P=.443). This translates to an 
      11% difference between active treatments in favor of 0.3% A/BPO. Also, 0.3% A/BPO 
      was safe and well tolerated. CONCLUSIONS: Availability of this new treatment 
      option should allow clinicians to better customize severe inflammatory acne 
      management, and the high-strength product provides a step-up treatment when 
      needed.
FAU - Weiss, Jonathan
AU  - Weiss J
FAU - Stein Gold, Linda
AU  - Stein Gold L
FAU - Leoni, Matthew
AU  - Leoni M
FAU - Rueda, Maria Jose
AU  - Rueda MJ
FAU - Liu, Hong
AU  - Liu H
FAU - Tanghetti, Emil
AU  - Tanghetti E
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Dermatologic Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Keratolytic Agents)
RN  - 1L4806J2QF (Adapalene)
RN  - W9WZN9A0GM (Benzoyl Peroxide)
SB  - IM
MH  - Acne Vulgaris/*drug therapy
MH  - Adapalene/administration & dosage/adverse effects/*therapeutic use
MH  - Adult
MH  - Benzoyl Peroxide/administration & dosage/adverse effects/*therapeutic use
MH  - Chemistry, Pharmaceutical
MH  - Dermatologic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Inflammation/drug therapy
MH  - Keratolytic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Male
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2015/12/15 06:00
MHDA- 2016/09/20 06:00
CRDT- 2015/12/15 06:00
PHST- 2015/12/15 06:00 [entrez]
PHST- 2015/12/15 06:00 [pubmed]
PHST- 2016/09/20 06:00 [medline]
AID - S1545961615P1427X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2015 Dec;14(12):1427-35.