A double blind randomized pilot clinical trial comparing the safety, tolerability and efficacy of combination of topical sodium fusidate and betamethasone valerate in biopolymer versus combination of fusidic acid and betamethasone valerate in the treatment of infected eczema.

ABSTRACT

Background: Eczema or dermatitis is a reaction pattern of the skin manifesting as itching, inflammation, redness, and swelling of the skin. There is currently no cure for eczema, but the condition can be controlled with a good treatment plan and newer strategies in formulation of existing drug can improve efficacy and acceptability. Aims: To evaluate the efficacy, tolerability and safety of topical Sodium Fusidate and Betamethasone Valerate in biopolymer Versus Combination of Fusidic acid and Betamethasone Valerate in the Treatment of Infected Eczema. Methods: This was a 6 week study in which patients had screening and randomization visit (day 0, visit 1), treatment assessments visits at week 2 (visit 2) and week 4 (visit 3) and a follow-up visit (visit4). The blinded medication was dispensed to patients. During visit 2 (after 2 weeks), a detailed skin examination and modified eczema scoring (12 points eczema score and 12 points of infection score with total of 24 points), Visual analogue scale for pruritus and global score index were carried out. Any adverse event was recorded. During visit 3 (week 4), clinical examination and laboratory examination (Hb%, TC, DC, ESR) was performed. Adverse events and patient compliance were also recorded during these visits. Results and Conclusions: Topical sodium fusidate and betamethasone valerate in biopolymer has shown to be more efficacious than topical sodium fusidate and betamethasone valerate. Both the combinations were well tolerable and safe.