PMID- 19911678
OWN - NLM
STAT- MEDLINE
DCOM- 20091209
LR  - 20151119
IS  - 0011-4162 (Print)
IS  - 0011-4162 (Linking)
VI  - 84
IP  - 4
DP  - 2009 Oct
TI  - Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels 
      in the management of acne vulgaris.
PG  - 223-9
AB  - This study investigated the efficacy, tolerability, and safety of 2 fixed-dose 
      combination gels for the treatment of facial acne: clindamycin 1%-benzoyl 
      peroxide 5% gel with hydrating excipients (C/BPO HE) and adapalene 0.1%-benzoyl 
      peroxide 25% gel (A/BPO). After 12 weeks of once daily treatment, the mean 
      reduction in inflammatory lesion count was 76.8% and 72.2% in the C/BPO HE group 
      and A/BPO group, respectively (P = .076). Significantly more participants 
      achieved treatment success, which was defined as an improvement of 2 grades or 
      more from baseline to week 12 on the investigator's static global assessment 
      (ISGA) scale, with C/BPO HE (30.5% [58/190]) compared with A/BPO (21.8% [42/192]) 
      (P = .046), and treatment success was achieved more quickly with C/BPO HE (P = 
      .035). Both products also reduced noninflammatory (62.2% C/BPO HE vs 6 1.5% 
      A/BPO) and total lesion counts (69.1% C/BPO HE vs 67.1% A/BPO). Despite the 
      overall similar efficacy profile, C/BPO HE was better tolerated and safer than 
      A/BPO. In the tolerability assessments, erythema, dryness, peeling, pruritus, and 
      burning/ stinging were more frequent in the A/BPO group at all time points from 
      week 1 onward (P < .05). Treatment-related adverse events (AEs) occurred in 48.4% 
      (92/190) of participants in the C/BPO HE group compared with 78.6% (151/192) of 
      the A/BPO group. We conclude that C/BPO HE and A/BPO have similar efficacy in 
      treating inflammatory and noninflammatory acne lesions, but C/BPO HE achieves 
      better overall treatment success in less time coupled with a significantly better 
      tolerability profile and notably better safety profile.
FAU - Zouboulis, Christos C
AU  - Zouboulis CC
AD  - Department of Dermatology, Dessau Medical Center, Auenweg 38, 06847 Dessau, 
      Germany. christos.zouboulis@klinikum-dessau.de
FAU - Fischer, Tanja C
AU  - Fischer TC
FAU - Wohlrab, Johannes
AU  - Wohlrab J
FAU - Barnard, Jo
AU  - Barnard J
FAU - Alio, Alessandra B
AU  - Alio AB
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Cutis
JT  - Cutis
JID - 0006440
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Excipients)
RN  - 0 (Gels)
RN  - 0 (Naphthalenes)
RN  - 0 (clindamycin phosphate benzoyl peroxide combination)
RN  - 1L4806J2QF (Adapalene)
RN  - 3U02EL437C (Clindamycin)
RN  - W9WZN9A0GM (Benzoyl Peroxide)
SB  - IM
MH  - Acne Vulgaris/*drug therapy
MH  - Adapalene
MH  - Adolescent
MH  - Adult
MH  - Anti-Bacterial Agents/adverse effects/therapeutic use
MH  - Benzoyl Peroxide/administration & dosage/adverse effects/*therapeutic use
MH  - Child
MH  - Clindamycin/administration & dosage/adverse effects/*therapeutic use
MH  - Dermatologic Agents/administration & dosage/adverse effects/therapeutic use
MH  - Drug Combinations
MH  - Excipients/chemistry
MH  - Female
MH  - Gels
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Naphthalenes/administration & dosage/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - Single-Blind Method
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2009/11/17 06:00
MHDA- 2009/12/16 06:00
CRDT- 2009/11/17 06:00
PHST- 2009/11/17 06:00 [entrez]
PHST- 2009/11/17 06:00 [pubmed]
PHST- 2009/12/16 06:00 [medline]
PST - ppublish
SO  - Cutis. 2009 Oct;84(4):223-9.