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

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.

Efficacy and Safety of Halometasone Cream to Treat Chronic Generalized Eczema and the Effects of Halometasone Cream on Serum Cortisol Levels

“…It inhibits inflammation, epidermal hyperplasia, and allergic reactions, constrict blood vessels, and relieve pruritus. The mechanism of action of halometasone is that the drug can bind to steroid receptors to modulate the protein synthesis that is involved in the development of chronic generalized eczema and thus to regulate the function of inflammatory cells and lysosomes and ultimately to reduce inflammatory responses [ 6 – 8 ]. According to the instruction of halometasone cream, only 1.41% of halometasone cream used for consecutive 7 days on a lesion area of 400 cm 2 can be absorbed via the skin.…”