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 95 subjects (32 in AFC group, 31 in marketed cracked heal cream [MCHC] group, and 32 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. The mean xerosis score was significantly reduced (P < 0.01) in AFC group than other groups from baseline to end of study. Majority of the patients showed a significant (P < 0.01) improvement in xerosis assessment scale (normal skin) along with a significant (P < 0.01) reduction in skin roughness score, mean hyperkeratosis score, and mean overall clinical cutaneous score at the end of the study. Almost all the patients showed a significant overall improvement after the completion of the study. No significant posttreatment changes were observed in any of the vital or laboratory parameters. AFC is safe and effective for the treatment of cracked heels (planter xerosis).