Zinc Oxide 30% and Tocopherol Compared to 10% Zinc Oxide Ointment in the Treatment of Infant's Diaper Dermatitis: A Triple Blinded Controlled Randomized Trial

Abstract

Aim: Assessing the efficacy of an experimental treatment that lasted 5 days and used the paste of Zinc Oxide 30% and tocopherol / Vitamin E compared to the use of a 10% Zinc Oxide ointment in the treatment of diaper dermatitis (DD) affecting the newborn's skin and the premature infant with gestational age ≥ 34 weeks. Background. DD is a common inflammatory irritating condition among children and infants. In multiple clinical studies, mycosis has been isolated in up to 80% of children with DD which can be present for even three or more days. Design: Triple blinded controlled randomized trial. Methods: 169 infants with DD (aged <24 months) were randomized to receive either 10% zinc oxide ointment (n=64) or Zinc Oxide 30% and tocopherol ointment (n=65). Infants were treated with multiple applications for 5 days. The severity of dermatitis was evaluated at both baseline and the end of trial by using the Severity Classification of Diaper Dermatitis scale (SCDD). Results. Improvement in the severity of DD was observed in both treatment groups (P<0.01). There was not a statistically significant difference between the groups as determined by F (2.164) =0.151, p=0.860. There was not any adverse effect from either of the study products. Conclusion: There is not any difference on efficacy of both the treatments. No one mycosis emerged in both groups. Management protocols for DD has relevant role on the improvement of diaper dermatitis in infants and on onset mycosis reduction