AN Evaluation of A Variety of Skin CARE Formulations On Children 0 to 36 Months of AGE with Normal Skin

Skin care is used routinely to protect/minimize damage to adult skin and many claims are made around efficacy and safety. However, safety on pediatric skin is not well studied. The following body of work took the form of 3 different studies, though the protocols were identical aside from the formulations evaluated in each. The purpose of these studies was to evaluate 9 different formulations including barriers, antifungal formulations, cleansers and skin preps on a population 0-36 months of age. 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. A total of 92 subjects completed these studies.  All subjects were randomly assigned the 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 only 2 very mild adverse events. It was concluded that the formulations evaluated are safe for use on this population. It is hoped that studies of this type will allow for enhanced clinician education, patient safety and prove beneficial to facilities with respect to skin care.