PMID- 23839176
OWN - NLM
STAT- MEDLINE
DCOM- 20140210
LR  - 20130710
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 12
IP  - 6
DP  - 2013 Jun 1
TI  - A phase IV, open-label study evaluating the use of triple-combination therapy 
      with minocycline HCl extended-release tablets, a topical antibiotic/retinoid 
      preparation and benzoyl peroxide in patients with moderate to severe acne 
      vulgaris.
PG  - 619-25
AB  - BACKGROUND: Moderate to severe acne vulgaris is often treated with a combination 
      of an oral antibiotic, topical antibiotic/retinoid, and benzoyl peroxide (BP), 
      but data are limited on the efficacy of this and other combination regimens that 
      incorporate both oral and topical therapies.<BR> METHODS: Patients were required 
      to be aged 12-30 years with moderate to severe acne (grades 3-4 acne on the 
      Investigator's Global Assessment [IGA]) and deemed potential candidates for 
      treatment with isotretinoin. Enrolled patients were given triple-combination 
      therapy, defined in this study as oral minocycline HCl extended release 1 mg/kg 
      QD, 6% BP foaming cloths used QD, and clindamycin phosphate 1.2%/tretinoin 0.025% 
      gel applied QD, and were evaluated at baseline and weeks 2, 4, 8, and 12.<BR> 
      RESULTS: A total of 97 patients were enrolled in the study. At week 12, 89% of 
      patients had at least a one-grade improvement from baseline IGA and 96% had at 
      least a one-grade improvement from baseline Global Aesthetic Improvement Scale 
      score. Mean +/- SD in- flammatory, non-inflammatory, and total lesion counts 
      decreased from baseline by 61.8% +/- 38.3%, 48.8% +/- 34.5%, and 56.5% +/- 29.9%, 
      respectively. The percentage of patients evaluated as candidates for isotretinoin 
      by independent photographic review was 77% (69/90) at baseline and only 16% 
      (14/90) at week 12. Treatment-related adverse events (AEs) occurred in eight of 
      97 (8%) patients. Triplecombination therapy was not associated with any serious 
      AEs or AEs leading to discontinuation.<BR> CONCLUSION: Triple-combination therapy 
      was well tolerated and substantially reduced facial acne lesion counts, with 84% 
      of patients judged to no longer be candidates for isotretinoin therapy by study 
      end. These data support the clinical observation that a triple-combination 
      regimen incorporating oral minocycline (dosed by patient weight), BP foaming 
      cloths 6% QD, and clindamycin phosphate 1.2%/ tretinoin 0.025% gel QD can 
      substantially improve moderate to severe acne vulgaris.
FAU - Zaenglein, Andrea L
AU  - Zaenglein AL
AD  - Penn State College of Medicine/Hershey Medical Center, Department of Dermatology, 
      Hershey, PA, USA. azaenglein@hmc.psu.edu
FAU - Shamban, Ava
AU  - Shamban A
FAU - Webster, Guy
AU  - Webster G
FAU - Del Rosso, James
AU  - Del Rosso J
FAU - Dover, Jeffrey S
AU  - Dover JS
FAU - Swinyer, Leonard
AU  - Swinyer L
FAU - Stein, Linda
AU  - Stein L
FAU - Lin, Xiaoming
AU  - Lin X
FAU - Draelos, Zoe
AU  - Draelos Z
FAU - Gold, Michael
AU  - Gold M
FAU - Thiboutot, Diane
AU  - Thiboutot D
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
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 (Anti-Bacterial Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Gels)
RN  - 0 (Tablets)
RN  - 0 (clindamycin, tretinoin drug combination)
RN  - 3U02EL437C (Clindamycin)
RN  - 5688UTC01R (Tretinoin)
RN  - FYY3R43WGO (Minocycline)
RN  - W9WZN9A0GM (Benzoyl Peroxide)
SB  - IM
MH  - Acne Vulgaris/*drug therapy/pathology
MH  - Administration, Cutaneous
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Anti-Bacterial Agents/administration & dosage/adverse effects/therapeutic use
MH  - Benzoyl Peroxide/administration & dosage/adverse effects/therapeutic use
MH  - Child
MH  - Clindamycin/administration & dosage/adverse effects/therapeutic use
MH  - Delayed-Action Preparations
MH  - Dermatologic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Female
MH  - Gels
MH  - Humans
MH  - Inflammation/drug therapy/pathology
MH  - Male
MH  - Minocycline/administration & dosage/adverse effects/therapeutic use
MH  - Severity of Illness Index
MH  - Tablets
MH  - Treatment Outcome
MH  - Tretinoin/administration & dosage/adverse effects/therapeutic use
MH  - Young Adult
EDAT- 2013/07/11 06:00
MHDA- 2014/02/11 06:00
CRDT- 2013/07/11 06:00
PHST- 2013/07/11 06:00 [entrez]
PHST- 2013/07/11 06:00 [pubmed]
PHST- 2014/02/11 06:00 [medline]
AID - S1545961613P0619X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2013 Jun 1;12(6):619-25.