title: Evaluation of the efficacy, safety and tolerability of Tacrolimus ointment in Indian patients of moderate to severe atopic dermatitis: a multicentric, open label, phase III study.
abstract: OBJECTIVE
  Tacrolimus, a topical immunomodulator, has been introduced as a new treatment for moderate to severe atopic dermatitis. The present study was conducted to evaluate the efficacy, safety and tolerability of Tacrolimus ointment in patients of atopic dermatitis in an Indian setting.
  
  
  METHODS
  The present study was a prospective, open, multicentric, Phase III trial. The duration of study was 5 weeks, including a 3-week active treatment period, preceded by a 1-week washout phase and followed by a 1-week follow-up phase. Patients diagnosed to be suffering from moderate to severe atopic dermatitis as per the Rajka and Langeland criteria were treated with Tacrolimus ointment 0.03% twice daily. Efficacy was assessed by modified Eczema Area Sensitivity Index (mEASI) score, patient's and physician's global assessment. Tolerability and safety was assessed by physical examination, laboratory parameters and evaluation of adverse events.
  
  
  RESULTS
  There was a statistically significant decrease in the modified Eczema Area Sensitivity Index (mEASI) score (P< 0.05). Patient's and Physician's global evaluation of treatment was complete resolution to very good improvement in most of the patients. The laboratory values were within normal limits. The drug was well tolerated.
  
  
  CONCLUSIONS
  This study confirms the efficacy and safety of Tacrolimus ointment 0.03% in Indian patients of moderate to severe atopic dermatitis.
authors.affiliation: Glenmark Pharmaceuticals Limited, 801-813, Mahalaxmi Chambers, 22, Bhulabhai Desai Road, Mumbai-400026.
authors.forename: D G
authors.initials: DG
authors.lastname: Saple
authors.forename: R G
authors.initials: RG
authors.lastname: Torsekar
authors.forename: V
authors.initials: V
authors.lastname: Pawanarkar
authors.forename: V
authors.initials: V
authors.lastname: Wali
authors.forename: G
authors.initials: G
authors.lastname: Ravichandran
authors.forename: U R
authors.initials: UR
authors.lastname: Dhanalakshmi
authors.forename: N
authors.initials: N
authors.lastname: Dongre
authors.forename: C
authors.initials: C
authors.lastname: Ballary
authors.forename: A
authors.initials: A
authors.lastname: Desai