title: 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.
abstract: 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>
  
  
  CONCLUSIONS
  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.
authors.affiliation: Penn State College of Medicine/Hershey Medical Center, Department of Dermatology, Hershey, PA, USA. azaenglein@hmc.psu.edu
authors.forename: Andrea L
authors.initials: AL
authors.lastname: Zaenglein
authors.forename: Ava
authors.initials: A
authors.lastname: Shamban
authors.forename: Guy
authors.initials: G
authors.lastname: Webster
authors.forename: James
authors.initials: J
authors.lastname: Del Rosso
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Dover
authors.forename: Leonard
authors.initials: L
authors.lastname: Swinyer
authors.forename: Linda
authors.initials: L
authors.lastname: Stein
authors.forename: Xiaoming
authors.initials: X
authors.lastname: Lin
authors.forename: Zoe
authors.initials: Z
authors.lastname: Draelos
authors.forename: Michael
authors.initials: M
authors.lastname: Gold
authors.forename: Diane
authors.initials: D
authors.lastname: Thiboutot
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000279:Administration, Cutaneous; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001585:Benzoyl Peroxide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002981:Clindamycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D005782:Gels; D006801:Humans; D007249:Inflammation / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008911:Minocycline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D013607:Tablets; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D013607:Tablets; C117880:clindamycin, tretinoin drug combination; D002981:Clindamycin; D014212:Tretinoin; D008911:Minocycline; D001585:Benzoyl Peroxide