A meta-analysis of randomized controlled trials comparing various topical anti-bacterial, anti-fungal & steroid products alone and in combinations with biopolymer and without biopolymer in skin infection conditions

Objective- To compare the safety, efficacy and tolerability of topical antibiotic/steroid preparations with biopolymer versus reference products without biopolymer in human population. Materials and Methods- The data of seven different clinical studies conducted at different centers of India was obtained from the sponsor Apex Laboratories Private Limited, Chennai (India). All the data was pooled mainly into two categories- Apex products with biopolymer and Reference products without biopolymer. Further the meta-analysis was done for each study assessment scales used in the studies. Results- Apex products with biopolymer was found to be significant for Visual analogue scale, Signs and symptoms score, Global score index, Physician global evaluation score, Patient’s compliance score, Percentage wound contraction and Overall rating in comparison with Reference products without biopolymer. At the end of treatment, bacterial/fungal culture examination report was negative in 97.18%, 94.20% of patients who had been treated with Apex products with biopolymer and reference products without biopolymer respectively. Conclusion- The present study revealed that Apex products with biopolymer was more effective than Reference products without biopolymer in achieving clinical improvement or resolution of skin infection conditions.