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

• Main Authors: Dasiga Venkata Subrahmanya Pratap, Mariam Philip, Narayana T Rao, Hemangi R Jerajani, Sainath A Kumar, Maria Kuruvila, Latha S Moodahadu, Shilpi Dhawan
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2013-01-01
• Series: Indian Journal of Dermatology
• Subjects: 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
• Online Access: http://www.e-ijd.org/article.asp?issn=0019-5154;year=2013;volume=58;issue=2;spage=117;epage=123;aulast=Pratap
• ISSN: 0019-5154; 1998-3611

Aim: 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. Materials and 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. Conclusion: 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.