Little Study: A Clinical Safety and Efficacy Study of a Ceramide-enriched Nonsoap Cleanser (Syndet Bar) in Infants and Toddlers with Dry and Sensitive Skin

Abstract Background: Infant and toddler skin is structurally immature, making it more susceptible to dryness, barrier impairment, and irritant responses. Usage of cleansing products in early life supports hydration, barrier integrity, and physiological skin pH. Limited evidence highlights the need for clinical evaluation of syndet bars in dry and sensitive skin among the Indian pediatric population. Materials and Methods: This prospective, openlabel, singlearm study enrolled 30 infants and toddlers aged 0–36 months. The test product was used once daily for 15 days. Instrumental assessments measured changes in skin hydration, transepidermal water loss (TEWL), and skin surface pH from baseline. Investigator evaluated skin dryness, mildness, gentleness, and irritation. Caregiver perceptions were captured using a structured questionnaire. Safety was evaluated by monitoring product-emergent adverse events. Statistical analyses were conducted using SPSS software. Ethics approval was obtained prior to study initiation. Results: After 15 days, skin hydration increased significantly (24.14 ± 3.51–30.33 ± 3.78), while TEWL decreased (12.97 ± 2.37–10.59 ± 2.02), indicating improved barrier function. Skin pH remained within the physiological acidic range. Investigator assessments showed significant improvements in dryness, mildness, gentleness, and irritation ( P < 0.001). Caregivers reported high acceptability, perceived gentleness, and overall satisfaction. No productrelated adverse events were observed. Conclusion: Once daily use of the Ceramide Enriched Nonsoap Cleanser (Syndet Bar) was safe, well tolerated, and effective in improving hydration, supporting barrier integrity, and maintaining physiological pH in infants and toddlers with dry and sensitive skin. Further controlled studies are warranted to validate longterm benefits.