title: Efficacy and safety of topical halometasone in eczematous dermatoses in Indian population: an open label, noncomparative study.
abstract: BACKGROUND
  Topical steroids remain the mainstay of treatment in eczema, an inflammatory skin reaction characterized by pruritus, redness, scaling, and clustered oozing papulovesicles. Halometasone is a new potent corticosteroid approved in the Indian market for topical application in the treatment of dermatitis.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of halometasone in the treatment of acute or chronic noninfected eczematous dermatosis in Indian population.
  
  
  METHODS
  A prospective, open, multicentric, phase 3, noncomparative clinical trial conducted at outpatient departments of seven centres. Two hundred endogenous eczema patients meeting study criteria were enrolled. Halometasone 0.05% cream was applied twice daily for 30 days in chronic and 20 days in acute eczema patients. Calculation of eczema area and severity index, and assessment of investigator's global assessment of severity of eczema and severity of pruritus score were done at each visit and compared with baseline. All adverse events (AE) were captured and documented. Laboratory investigations including haematological tests, urinalysis, renal and liver function tests were performed at baseline and at end of treatment.
  
  
  RESULTS
  Of the 200 patients enrolled, 180 were chronic and 20 were acute eczema patients. It was found that there was a significant (P<0.001) improvement in all efficacy parameters compared with baseline. The treatment was shown to be successful in 91% patients. AE were reported in 30 patients and there was no serious AE reported. There was no clinically significant difference in laboratory investigations with treatment.
  
  
  CONCLUSIONS
  Halometasone was shown to be safe and very effective in Indian patients with acute and chronic eczema and the drug was well tolerated.
authors.affiliation: Department of Dermatology, LTM Medical College and LTM General Hospital, Mumbai, India .
authors.forename: H R
authors.initials: HR
authors.lastname: Jerajani
authors.forename: A S
authors.initials: AS
authors.lastname: Kumar
authors.forename: Maria
authors.initials: M
authors.lastname: Kuruvila
authors.forename: H V
authors.initials: HV
authors.lastname: Nataraja
authors.forename: Mariam
authors.initials: M
authors.lastname: Philip
authors.forename: D V S
authors.initials: DV
authors.lastname: Pratap
authors.forename: T K
authors.initials: TK
authors.lastname: Sumathy
authors.forename: Binny
authors.initials: B
authors.lastname: Krishnankutty
authors.forename: Shilpi
authors.initials: S
authors.lastname: Dhawan
authors.forename: Dennis
authors.initials: D
authors.lastname: Thomas