Cutaneous tolerance of baby wipes by infants with atopic dermatitis, and comparison of the mildness of baby wipe and water in infant skin.

To confirm the safety and cutaneous tolerability of a new brand of baby wet wipes, we conducted the following clinical studies: (i) a double-blind in-use study in 102 infants over a period of 2 weeks, to compare skin tolerance of the wipes vs. water and a cleansing material (ii) a chamber scarification test on adults to assess the skin irritation potential of the baby wipe, and (iii) a 4-week clinical in-use study in 60 babies with atopic dermatitis, to confirm safety and skin tolerability in a sensitive skin subpopulation. In the clinical comparison with water and cleansing material, skin conditions were assessed visually for presence and severity of erythema and diaper dermatitis. The overall skin condition was not different in the group using wipes and in the group using only water and a cleansing material, indicating comparable skin mildness for both regimes. The chamber scarification test confirmed that the lotion contained in the wipe has a very low irritation potential, lower than that of a currently marketed baby wipe and comparable to that of water under occlusive patch test conditions. The good skin tolerance of the wipes was supported by the observations of a dermatologist in the clinical study in babies with atopic dermatitis. These data strongly support the suitability of the baby wipes tested in these studies for daily cleansing of the diapered area, even for infants with sensitive skin. These data also provide useful information regarding the comparative skin mildness of baby wipes and water.

RCT Entities:   Population Interventions Outcomes