title: Efficacy and safety of a nano-emulsion gel formulation of adapalene 0.1% and clindamycin 1% combination in acne vulgaris: a randomized, open label, active-controlled, multicentric, phase IV clinical trial.
abstract: BACKGROUND
  Acne vulgaris is a very common skin disease with a significant detrimental effect on the quality of life of the patients.
  
  
  OBJECTIVE
  To assess the comparative efficacy and safety of a nano-emulsion gel formulation of adapalene and clindamycin combination with its conventional formulation in the treatment of acne vulgaris of the face. It was a prospective, randomized, open label, active-controlled, multicentric, clinical trial.
  
  
  METHODS
  Eligible patients suffering from acne vulgaris of the face were randomized to receive once-daily treatment with a nano-emulsion gel or conventional gel formulation of adapalene 0.1% and clindamycin (as phosphate) 1% combination for 12 weeks. Total, inflammatory and noninflammatory lesion counts, with grading of acne severity were carried out on a monthly basis. Safety assessments were done to determine the comparative local and systemic tolerability. Two-tailed significance testing was carried out with appropriate statistical tests, and P-values < 0.05 were considered as significant.
  
  
  RESULTS
  209/212 patients enrolled in the study were eligible for efficacy and safety assessments in both nano-emulsion gel (118/119 patients) and conventional gel (91/93 patients) groups. Significantly better reductions in total (79.7% vs. 62.7%), inflammatory (88.7% vs. 71.4%) and noninflammatory (74.9% vs. 58.4%) lesions were reported with the nano-emulsion gel as compared to the conventional gel (P < 0.001 for all). Mean acne severity score also reduced significantly more with the nano-emulsion formulation (1.9 ± 0.9 vs. 1.4 ± 1.0; P < 0.001) than the comparator. Significantly lower incidence and lesser intensity of adverse events like local irritation (4.2% vs. 19.8%; P < 0.05) and erythema (0.8% vs. 9.9%; P < 0.05) were recorded with the nano-emulsion gel.
  
  
  CONCLUSIONS
  The nano-emulsion gel formulation of adapalene and clindamycin combination appears to be more efficacious and better tolerated than the conventional formulation for the treatment of acne vulgaris in Indian patients. Further studies can elucidate the comparative treatment benefits of this nano-emulsion gel formulation.
authors: CliSkin Care Centre, Chidambaram, India.
authors: Siva
authors: S
authors: Prasad
authors: Amiya
authors: A
authors: Mukhopadhyay
authors: Amit
authors: A
authors: Kubavat
authors: Amit
authors: A
authors: Kelkar
authors: Ajay
authors: A
authors: Modi
authors: Bhavesh
authors: B
authors: Swarnkar
authors: Bobby
authors: B
authors: Bajaj
authors: Maya
authors: M
authors: Vedamurthy
authors: Shafiq
authors: S
authors: Sheikh
authors: Ravindra
authors: R
authors: Mittal
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002981:Clindamycin / Q000009:adverse effects / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004655:Emulsions; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D036103:Nanotechnology; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; D004655:Emulsions; D005782:Gels; D009281:Naphthalenes; D000068816:Adapalene; D002981:Clindamycin