title: Clindamycin 1% Nano-emulsion Gel Formulation for the Treatment of Acne Vulgaris: Results of a Randomized, Active Controlled, Multicentre, Phase IV Clinical Trial.
abstract: BACKGROUND
  Acne vulgaris of the face is a common dermatological disease with a significant impact on the quality of life, psychosocial development as well as self-esteem of the patients. Nano emulsion gel formulations are said to have various advantages over the conventional formulations.
  
  
  OBJECTIVE
  The present study was conducted to assess the comparative efficacy and safety of a nano-emulsion gel formulation of clindamycin with its conventional formulation in the treatment of acne vulgaris of the face.
  
  
  METHODS
  This prospective, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by a nano emulsion gel formulation or conventional gel formulation of clindamycin (as phosphate) 1% locally applied twice daily for 12 weeks as per random allocation. Acne lesion counts (inflammatory, non-inflammatory and total) and severity grading were carried out on the monthly scheduled visits along with tolerability assessments.
  
  
  RESULTS
  A total of 200 patients (97 males) were included for Intention to Treat analysis in the trial with 100 patients in each group. Reductions in total (69.3 vs. 51.9%; p<0.001), inflammatory (73.4 vs. 60.6%; p<0.005) and non inflammatory (65.1 vs. 43.7%; p<0.001) acne lesions were reported to be significantly greater with the nano-emulsion gel formulation as compared to the conventional gel formulation. Significantly more reduction in the mean acne severity score was noticeable with the nano-emulsion gel formulation (-1.6 ± 0.9 vs. -1.0 ± 0.8; p<0.001) than the comparator. A trend towards better safety profile of the nano emulsion gel formulation was reported.
  
  
  CONCLUSIONS
  In the treatment of acne vulgaris of the face, clindamycin nano emulsion gel formulation appears to be more effective than the conventional gel formulation and is also well tolerated.
authors.affiliation: Consultant Dermatologist, Lavanya Skin Clinic , Ahmedabad, India .
authors.forename: Bhavik
authors.initials: B
authors.lastname: Bhavsar
authors.affiliation: Consultant Dermatologist, Dr. Choksi's Clinic , Surat, India .
authors.forename: Bimal
authors.initials: B
authors.lastname: Choksi
authors.affiliation: Manager, Department of Regulatory Affairs, Cadila Healthcare Ltd . Ahmedabad, India .
authors.forename: Jayesh
authors.initials: J
authors.lastname: Sanmukhani
authors.affiliation: Consultant Dermatologist, Dr. Alka Dogra's Clinic , Ludhiana, India .
authors.forename: Alka
authors.initials: A
authors.lastname: Dogra
authors.affiliation: Consultant Dermatologist, Radiance Skin Clinic , Nagpur, India .
authors.forename: Rizwan
authors.initials: R
authors.lastname: Haq
authors.affiliation: Consultant Dermatologist, Mehta Clinic , Ratnagiri, India .
authors.forename: Sudhanshu
authors.initials: S
authors.lastname: Mehta
authors.affiliation: Consultant Dermatologist, Seth Diagnostic Centre , Kolkata, India .
authors.forename: Santanu
authors.initials: S
authors.lastname: Mukherjee
authors.affiliation: Consultant Dermatologist, Aswini Hospital , Villupuram, India .
authors.forename: V
authors.initials: V
authors.lastname: Subramanian
authors.affiliation: NDDS, Zydus Research Centre, Cadila Healthcare Ltd ., Ahmedabad, India .
authors.forename: Shafiq
authors.initials: S
authors.lastname: Sheikh
authors.affiliation: Senior Vice-President, Department of Regulatory Affairs, Cadila Healthcare Ltd . Ahmedabad, India .
authors.forename: Ravindra
authors.initials: R
authors.lastname: Mittal
keywords: Acne Vulgaris; Clindamycin; Clinical Trial; Nano emulsion