Evaluation of efficacy and safety of Amarantha footcare cream in subjects suffering from cracked heels (xerosis of the feet): A randomized, open labeled, multi-centric, comparative, interventional, prospective, clinical study

Abstract

Xerosis of the foot can lead to cracks in plantar surface with discomfort, pain, and predisposition to infection. This study was conducted to evaluate the comparative efficacy and safety of Amarantha footcare cream (AFC) in subjects suffering from cracked heels (xerosis of feet). A total of 79 subjects (26 in AFC group, 26 in marketed cracked heal cream [MCHC] group, and 27 in Amarantha wound healing cream [AWHC] group) were completed the study. All trial subjects were advised to apply sufficient quantity of given creams, twice daily for 28 days or till complete clearance of the cracked heel, whichever was earlier. Study subjects were called for follow-up visits on days 7, 14, 21, and 28. Clinical trial registry of India registration number is CTRI/2020/11/028829. The mean days required for complete healing of cracked heel were 16.69, 22.96, and 25.74 in AFC, MCHC, and AWHC groups respectively. The mean xerosis score was significantly reduced (P < 0.01) in AFC group than other groups from baseline to end of study. Overall clinical cutaneous score was significantly (p < 0.01) reduced in AFC group as compared to other two groups on day 7, 14 and 21. AFC group showed overall very much improvement than other two groups at the end of the study. Few adverse events were reported; however, none was related to study drugs. AFC is safe and effective for the treatment of cracked heels (planter xerosis).