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.

Pratap, Dasiga Venkata Subrahmanya and Philip, Mariam and Rao, Narayana T and Jerajani, Hemangi R and *, Sainath A Kumar and Kuruvila, Maria and Moodahadu, Latha S and Dhawan, Shilpi (2013) 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. Indian Journal of Dermatology, 58 (2). pp. 117-123. ISSN 0019-5154

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Abstract

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.

Item Type: Article
Uncontrolled 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
Subjects: Medicine > KMC Mangalore > Dermatology
Depositing User: KMCMLR User
Date Deposited: 17 Oct 2016 14:42
Last Modified: 17 Oct 2016 14:42
URI: http://eprints.manipal.edu/id/eprint/147200

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