Topical Breast Milk plus Zinc Oxide Versus Zinc Oxide Alone for Diaper Rash in Infants Under 1 Year: A Randomized Clinical Trial

Abstract

Background:

Diaper dermatitis (DD) is a common inflammatory skin condition in infants, typically managed with supportive care and anti-inflammatory treatments. This study aimed to evaluate the efficacy of topical breast milk combined with zinc oxide versus zinc oxide alone in treating DD in infants.

Methods:

A randomized clinical trial was conducted at Bahrami Children’s Hospital from 2022 to 2023. Forty-two infants with clinically diagnosed DD were randomly assigned to two groups: the control group received 25% zinc oxide ointment, while the case group received 25% zinc oxide combined with topical breast milk. Both treatments were applied for 7 consecutive days. The severity of DD was assessed daily using the Buckley Diaper Dermatitis Severity Scale, and lesion improvement was documented.

Results:

The mean age of the infants was 2.93 ± 7.41 months, and 52.4% were male. No significant differences were observed between the two groups in baseline characteristics. Complete and partial recovery rates in the case group were 61.9% and 38.1%, respectively, compared to 66.6% and 19.1% in the control group. Notably, no non-responders were found in the case group, while 14.3% in the control group showed no response to treatment. The case group experienced faster lesion resolution (2.52 ± 0.67 days vs. 3.28 ± 1.14 days, p = 0.012).

Conclusion:

Topical breast milk combined with zinc oxide may reduce recovery time in treating diaper dermatitis. This approach is safe, cost-effective, and accessible. Larger randomized trials are needed to confirm these results and establish standardized treatment protocols.