Evidence map›Paper›PMID 40189822›Full record

Trial reportPediatric dermatology

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

R J O'Connor, Marty O Visscher, Vivek Narendran, Y Wang, F Wiesemann, A N Carr

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric dermatology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

R J O'ConnorThe Procter & Gamble Company, Cincinnati, Ohio, USA.
Marty O VisscherJames L. Winkle College of Pharmacy, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
Vivek NarendranPerinatal Institute, Cincinnati Children's Hospital Medical Center, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.
Y WangThe Procter & Gamble Company, Cincinnati, Ohio, USA.
F WiesemannThe Procter & Gamble Company, Schwalbach am Taunus, Germany.
A N CarrThe Procter & Gamble Company, Cincinnati, Ohio, USA.ORCID https://orcid.org/0000-0003-1676-8033

Funding

Procter and Gamble
6 · The paper itself

Abstract

BACKGROUND/

objectivesSkin 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.

methodsA 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.

resultsBabies 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.

conclusionsCollectively, 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.

Indexed as

Diaper RashDiapers, InfantEmollientsErythemaPetrolatumAdultCross-Over StudiesFemaleHumansInfantMaleEmollientsPetrolatumdiaperdiaper dermatitisemollienterythemapetrolatumshea butter

Identifiers

PMID40189822
PMCPMC12118526

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.