Evaluation of safety and efficacy of prickly heat baby powder in 0-36 months babies

Background: Given the unique sensitivity of baby skin, this study emphasizes the importance of effective skincare products that cater to the delicate nature of young children's skin. This study was conducted to evaluate the safety, tolerability and efficacy of "Prickly Heat Baby Powder," a polyherbal formulation designed to alleviate symptoms associated with prickly heat in infants and toddlers. Methods: This was an open-label, single-arm, multicentric study was conducted across 24 medical facilities in India, the trial involved 500 healthy full-term newborns, infants and toddlers aged 0–36 months. Over a 15 (+1) day period, parents/LAR were instructed to apply the powder after bath and nappy changes. Results: The study assessed product tolerability and efficacy through paediatric evaluations and subjective feedback from parents. Results indicated that 68.6% of subjects experienced significant symptom resolution, with the product rated as mild and gentle for infant skin. No adverse effects were reported and a high acceptance rate was noted among subjects. Conclusions: The formulation's natural ingredients, including Yashada bhasma, Neem, Karanja and Khus Khus, were highlighted for their antiseptic and anti-inflammatory properties, making it a safe alternative to conventional products. This study supports the potential of herbal formulations in paediatric dermatology and suggest that "Prickly Heat Baby Powder" effectively addresses the discomfort associated with prickly heat, aligning with the growing consumer preference for natural skin care solutions for children.