title: A randomized, double-blind, placebo-controlled, pilot study to assess the efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for the treatment of acne rosacea over 12 weeks.
abstract: BACKGROUND
  Papulopustular acne rosacea is a chronic inflammatory condition which can be difficult to treat. Many patients are unwilling to use systemic medications, and single topical agents alone may not address all the symptoms of rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025% gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne vulgaris and rosacea shares many similar clinical and histologic features.
  
  
  OBJECTIVE
  To assess the preliminary efficacy and safety of a combination gel consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular rosacea after 12 weeks of usage.
  
  
  METHODS
  Randomized, double-blind, placebo controlled two site study of 79 participants with moderate to severe papulopustular acne rosacea using both physician and subjects' validated assessment tools. Primary endpoint consisted of statistically significant reduction in absolute papule or pustule count after 12 weeks of usage.
  
  
  RESULTS
  There was no significant difference in papule/pustule count between placebo and treated groups after 12 weeks (P=0.10). However, there was nearly significant improvement in physicians' assessments of the telangiectasia component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype (P=0.05) in treated versus placebo group after 12 weeks. The only significant adverse event different was facial scaling, which was significantly increased in treated group (P=0.01), but this did not result in discontinuation of study drug.
  
  
  CONCLUSIONS
  A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025% may improve the telangiectatic component of rosacea and appears to better treat the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype. Our preliminary study suggests that future studies with much larger sample size might confirm our findings.
authors.affiliation: Stanford University School of Medicine, Redwood City, CA, USA.
authors.forename: Anne Lynn S
authors.initials: AL
authors.lastname: Chang
authors.forename: Maria
authors.initials: M
authors.lastname: Alora-Palli
authors.forename: Xinaida T
authors.initials: XT
authors.lastname: Lima
authors.forename: Tiffany C
authors.initials: TC
authors.lastname: Chang
authors.forename: Carol
authors.initials: C
authors.lastname: Cheng
authors.forename: Connie M
authors.initials: CM
authors.lastname: Chung
authors.forename: Omar
authors.initials: O
authors.lastname: Amir
authors.forename: Alexa B
authors.initials: AB
authors.lastname: Kimball
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002981:Clindamycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012393:Rosacea / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; C117880:clindamycin, tretinoin drug combination; D002981:Clindamycin; D014212:Tretinoin