title: Efficacy and tolerability of topical fixed combination of nadifloxacin 1% and adapalene 0.1% in the treatment of mild to moderate acne vulgaris in Indian patients: a multicenter, open-labelled, prospective study.
abstract: BACKGROUND
  A combination of topical retinoid and antibacterial therapy is often advocated for acne to enhance therapeutic efficacy.
  
  
  OBJECTIVE
  A preliminary study to evaluate the efficacy and tolerability of a topical fixed combination of nadifloxacin (1%) and adapalene (0.1%) in the treatment of mild to moderate acne in Indian patients.
  
  
  METHODS
  This was an open-labeled, phase 3 non-randomized, non-comparative study conducted at five centers (Ahmedabad, Nagpur, Thane, Bangalore, and Mumbai) across India. Of 119 enrolled patients with mild to moderate acne, 117 patients were evaluated at the end of the study for efficacy parameters. A fixed combination of nadifloxacin (1%) and adapalene (0.1%) topical gel was applied at the affected area once at night for a period of 8 weeks. Reduction in the total, inflammatory and non-inflammatory lesion counts from the baseline, investigator global assessment (IGA) and reduction in the severity of acne as per combined acne severity classification were the primary efficacy variables measured at 2 weeks, 4 weeks, and 8 weeks.
  
  
  RESULTS
  Overall, 98.3% patients showed a statistically significant progressive reduction in non-inflammatory lesion counts, inflammatory lesion counts, and total lesion counts over the study duration. By the end of 8 weeks, 75% of the patients had their global assessment scores approaching to normal healthy skin score. The adverse events were mild to moderate in severity.
  
  
  CONCLUSIONS
  This preliminary study shows that a fixed combination of 1% nadifloxacin and 0.1% adapalene topical gel could be an effective and well-tolerated option for the treatment of mild to moderate acne vulgaris. However, further well-controlled, randomized and comparative evaluation of this combination is necessary.
authors: Department of Dermatology, BJ Medical College and Civil Hospital, Asarwa Ahmedabad, Gujrat, India.
authors: Bela Jaswantlal
authors: BJ
authors: Shah
authors: Department of Dermatology, M.S. Ramaiah Medical College, MSR Nagar MSRIT, Bangalore, India.
authors: Tharayil Kunneth
authors: TK
authors: Sumathy
authors: Department of Dermatology, Lokmanya Tilak Muncipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion, Mumbai, Maharahstra, India.
authors: Rachita Savalaram
authors: RS
authors: Dhurat
authors: Department of Dermatology, Rajiv Gandhi Medical College and Chatrapathi Shivaji Maharaj Hospital, Kalwa, Thane, Maharahstra, India.
authors: Raghunandan Govind
authors: RG
authors: Torsekar
authors: Department of Dermatology, Rajiv Gandhi Medical College and Chatrapathi Shivaji Maharaj Hospital, Kalwa, Thane, Maharahstra, India.
authors: Vishalakshi
authors: V
authors: Viswanath
authors: Mukhi Skin Clinic, 103 Heera Plaza, Near Telephone Exchange Square, Central Avenue, Nagpur, Maharahstra, India.
authors: Jayesh Ishwardas
authors: JI
authors: Mukhi
authors: Medical Affairs Department, Wockhardt Ltd, Wockhardt Towers, Bandra Kurla Complex, Mumbai, Maharahstra, India.
authors: Ganesh
authors: G
authors: Kadhe
authors: Medical Affairs Department, Wockhardt Ltd, Wockhardt Towers, Bandra Kurla Complex, Mumbai, Maharahstra, India.
authors: Pashmina
authors: P
authors: Ahirrao
keywords: Acne; dermatology; fixed combination; topical