Tolerance of baby cleansers in infants: a randomized controlled trial.

This randomized controlled trial was conducted to evaluate the tolerability of a new baby cleanser formulation Johnsons Top-to-Toe cleanser (JTT) on infantile skin. 180 healthy infants (60 in each group) were enrolled and JTT Sebamed Baby Liquid cleanser (SM), and lukewarm tap water were used on the skin of the subjects as whole body cleansers twice a week for 2 weeks. Assessment was done at baseline, 1 week and 2 weeks clinically by a dermatologist, instrumentally, and by the parents. Clinical assessment (erythema, edema, dryness and scaling); skin moisture content; skin surface pH; trans-epidermal water loss; skin oxyhemoglobin and deoxyhemoglobin; and consumer satisfaction were the outcome measures. There was no significant erythema, edema, dryness, or scaling elicited by any of the three test components. Parents did not report any side-effects. All the three studied interventions used as whole body cleansers were efficacious and well tolerated by infants.

RCT Entities:   Population Interventions Outcomes