Clinical Evaluation of a Diaper Containing a Shea Butter-Based Emollient and Impact on Diapered Skin Erythema.

Background/objectives: Skin is a baby's first line of defense against mechanical, chemical, enzymatic, and microbial insults. Preventive interventions in the diapered area are important given repetitive, episodic exposures to irritants in urine and feces. For over a century, physicians have utilized petrolatum-based emollients (PBE) prophylactically and retroactively for skin irritation in the diapered area. In this study, a diaper containing an anhydrous, shea butter-based emollient (SBE) was evaluated for its skin effects on adult and baby skin.

Methods: A 6-week, randomized, crossover, on-baby study was conducted to compare diapered skin erythema from PBE-, SBE-, or non-emollient-containing diapers. Quantification of emollient transfer from diaper to baby was also determined, and two adult forearm studies evaluated emollient effects to lessen irritation by sodium lauryl sulfate (SLS) or prevent skin overhydration.

Results: Babies who transitioned from the PBE-containing diaper to the no emollient diaper exhibited a significant increase in skin erythema, whereas no increase was observed for those transitioning from the PBE to the SBE diaper. Babies wearing the SBE diaper were 2.6x more likely to be free of erythema (score = 0) at the perianal site versus the non-emollient diaper, whereas the proportion of erythema-free babies was similar between PBE and SBE diapers, consistent with their similar protection of skin in the adult forearm models.

Conclusions: Collectively, these studies demonstrate a disposable diaper containing an emollient protects diapered skin versus diapers without emollients. SBE was as effective in mitigating erythema, was well-tolerated, and provided similar protection as the PBE in a diaper context.