Development and validation of calamine lotion infused with vitamin C, vitamin E and chlorpheniramine

This study is a pilot interventional trial designed to develop and validate a novel topical calamine lotion formulation infused with vitamin C, vitamin E and chlorpheniramine for the management of dermatitis in children. Dermatitis is a common paediatric dermatological condition associated with significant pruritus, sleep disturbance and caregiver burden, often requiring safe and effective topical therapies suitable for long-term use.The study will be conducted at the Department of Paediatrics, Saveetha Medical College and Hospital, Chennai, after obtaining Institutional Ethics Committee approval. Children aged 2-12 years diagnosed clinically with dermatitis, including allergic dermatitis, psoriasis and lichen planus, will be recruited after obtaining informed consent from parents or legal guardians.Following a baseline observation period of two weeks, eligible participants will receive topical application of the study formulation for a duration of four weeks. Participants will be monitored at predefined intervals for clinical response and safety. The primary outcome of the study is reduction in pruritus severity, assessed using a validated itch scoring system. Secondary outcomes include improvement in sleep quality, caregiver satisfaction, treatment adherence and tolerability of the formulation.This pilot study aims to generate preliminary evidence regarding the efficacy, safety and acceptability of the fortified calamine lotion in paediatric dermatitis. The findings are expected to inform the feasibility and design of larger randomized controlled trials and contribute to the development of affordable, child-friendly topical treatment options for inflammatory skin disorders.