PEDIATRIC DERMATOLOGICAL SAFETY OF BABYORGANO HING ROLL-ON: A CLINICAL TRIAL ON HEALTHY HUMAN VOLUNTEERS

The skin irritation potential of BabyOrgano Hing Roll-On, a natural topical remedy designed to alleviate colic and digestive discomfort in infants, was assessed through a single-application patch test on healthy adult human subjects. In this skin irritation potential Clinical trial involving 24 volunteers. Patch testing was performed using three patches: Patch 1 with BabyOrgano Hing Roll-On, Patch 2 as a negative control (0.9% isotonic saline), and Patch 3 as a positive control (1% sodium lauryl sulfate). Patches were applied for 24 hours and skin reactions were evaluated at multiple time points: T0 (baseline), T1 (immediate post-removal), T2 (24 hours post-removal), and T8 (one-week post-removal). Reactions were assessed by both a pediatrician and a dermatologist using the Draize scale for erythema and oedema. The primary endpoint was the total irritation score 24 hours after patch removal. Results showed no skin irritation (mean score = 0) with Patch 1 and Patch 2, while Patch 3 showed a mean irritation score of 4.33, confirming its expected irritant response. No adverse events, dropouts, or delayed reactions were observed. These findings confirm that BabyOrgano Hing Roll-On is dermatologically safe and non-irritant for application on human skin, supporting its suitability for use in pediatric populations.