title: Evaluation of Efficacy, Safety, and Tolerability of Fixed Dose Combination (FDC) of Halometasone 0.05% and Fusidic Acid 2% W/W Topical Cream Versus FDC of Betamethasone Valerate 0.12% and Neomycin Sulphate 0.5% W/W Topical Cream in the Treatment of Infected Eczematous Dermatosis in Indian Subjects: A Randomized Open-Label Comparative Phase III Multi-Centric Trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of fixed drug combination (FDC) halometasone 0.05% and fusidic acid 2% (group A) vs FDC betamethasone 0.12% and neomycin sulfate 0.5% cream (group B) in acute or chronic infected eczematous dermatosis, through a randomized open-label, comparative, multicentric study.
  
  
  METHODS
  A total of 152 patients were randomized to either Group A or Group B. EASI (Eczema Area and Severity Index), IGA (Investigator's global assessment), scale for severity of eczema, pruritus, and safety parameters were assessed at baseline, Day 5/Day 10, Day 10/20, and Day 20/Day 30 for acute/chronic cases. Skin swabs were tested at screening, Day 10, and end of the study.
  
  
  RESULTS
  Staphylococcus aureus was the frequently encountered causative agent. There was a significant reduction within the study groups in EASI, IGA scales for severity of eczema, pruritus at various visits, compared to baseline. At the end of study, 83.87% in group A and 65.71% in group B were culture negative. Cure rate was 54.28% and 50% in group A and B, respectively. Five adverse events were reported in five patients, of which three patients withdrew from the study.
  
  
  CONCLUSIONS
  Halometasone 0.05% and Fusidic acid 2% cream is effective, safe, well tolerated with comparable efficacy to the comparator in the treatment of acute and chronic infected eczematous dermatosis.
authors.affiliation: Department of Dermatology and Venerology, Osmania Medical College and Hospital, Hyderabad, Andhrapradesh, India.
authors.forename: Dasiga Venkata Subrahmanya
authors.initials: DV
authors.lastname: Pratap
authors.forename: Mariam
authors.initials: M
authors.lastname: Philip
authors.forename: Narayana T
authors.initials: NT
authors.lastname: Rao
authors.forename: Hemangi R
authors.initials: HR
authors.lastname: Jerajani
authors.forename: Sainath A
authors.initials: SA
authors.lastname: Kumar
authors.forename: Maria
authors.initials: M
authors.lastname: Kuruvila
authors.forename: Latha S
authors.initials: LS
authors.lastname: Moodahadu
authors.forename: Shilpi
authors.initials: S
authors.lastname: Dhawan
keywords: Betamethasone 0.12% and neomycin sulfate 0.5% cream; eczema area and severity index; halometasone 0.05% and fusidic acid 2% cream; investigator's global assessment scale for severity of eczema; pruritus