AN Evaluation of HEALTHCARE PRODUCTS On Children 0 to 36 Months of AGE with Normal Skin

The barrier property of skin can be compromised by a variety of agents/activities, such as adhesive trauma, irritation caused by urine and/or fecal incontinence, digestive juices, and shear/friction. All of which can lead to a wound.  Film forming skin protectants have been used routinely to minimize damage to adult skin, yet the effect on pediatric skin is not well studied. The purpose of this study (single-center, randomized, evaluator blinded) was to evaluate a new (non-stinging) formulation and two marketed adhesive removers on children with normal skin. The primary objective was to assess safety through visual evaluations and assessment of subjective questionnaires, diary comments and adverse events during a 4-week period of use. Thirty subjects (0 to 36 months of age) completed the study.  All subjects were randomly assigned all three test articles and an untreated site. Each subject was visually evaluated for irritation (dryness and erythema) by a trained grader. Each forearm and buttock was evaluated separately and given a score of 0-3. At week 2 each subject was visually evaluated for irritation by a trained grader. The subject's parent or legal guardian completed a subjective questionnaire and diaries were reviewed. Adverse events were assessed and concomitant medications were reviewed. At week 4 each subject was visually evaluated for irritation by a trained grader.  The subject's parent or legal guardian completed a subjective questionnaire. Diaries and test articles were collected. The data indicated no scores above ‘0’ for the no sting formulation, though one adhesive remover had scores of 1, 0.5 and 0.5; the other 1.0 and 0.5. A total of 5 adverse events, though these scores indicated very slight/barely noticeable erythema/irritation. As no adverse events were noted for the no- sting formulation, it was concluded that the  no-sting formulation is safe for use on this population.