A prospective, open-label in-use tolerance study of a ceramide-based moisturizing cream in infants and children

Objectives: This study aimed to evaluate the in-use tolerance of a ceramide-containing moisturizer in infants and children over 15 days. Materials and Methods: This was a prospective, monocentric, open-label study conducted in children aged 3 months to 12 years with apparently healthy skin. Participants applied the test formulation at least twice daily for 15 days. Clinical evaluations were conducted on Day 1 and Day 15 to assess skin reactions (erythema and edema) using the Draize scale. Parents maintained daily logs and completed a structured feedback questionnaire at study completion. Children with active skin disorders, atopic dermatitis, or systemic illness were excluded. Compliance was monitored through usage logs and returned product containers. Data were analyzed descriptively. Results: A total of 35 participants (18 boys and 17 girls) with a mean age of 5.13 ± 3.07 years completed the study. No adverse skin reactions (erythema or edema) were observed in any participant by the end of the study period. Questionnaire responses indicated high parental satisfaction, with 100% of parents agreeing that the cream was mild and gentle on their child’s skin, improved skin softness and suppleness, and was suitable for daily use. No parent reported issues such as redness, dryness, roughness, or itching. No adverse events were observed. Conclusion: Excellent in-use tolerance was observed in infants and children after 15 days of regular application of the test formulation. The product was well accepted by parents, with no clinical or subjective reports of irritation or adverse effects. These findings substantiate the safe, routine application of a ceramide-based moisturizing formulation in pediatric skin care.