Evaluation of the Impact of 2 Disposable Diapers in the "Natural" Diaper Category on Diapered Skin Condition

Abstract

The demand for natural infant care products, including diapers, has increased. However, few disposable diapers have been able to provide the performance caregivers desire while also incorporating ingredients consistent with the "natural" category. In an examiner-blinded clinical study, the performance of a new cotton-enhanced diaper with high-performance materials was compared with an existing natural diaper offering. A total of 131 infants wore 1 of the 2 diapers for a 4-week period. Diaper performance was assessed based on skin marking assessments, scored by a trained grader, and incidence of diaper dermatitis. Skin grading for diaper dermatitis was assessed at 4 sites in the diaper area. The new diaper offering was associated with less skin marking and significantly less diaper rash at the genitals and intertriginous regions versus the comparator. These data suggest that the new diaper provided significant improvement in both skin marking and prevalence of diaper rash.

Keywords: diaper dermatitis; diaper performance; diaper technology; irritant contact dermatitis; natural.

Conflict of interest statement

Declarations of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Robert J. O’Connor, Andrew N. Carr, Y. Wang, Roger Gibb, and Veronica Sanchez are full-time employees at Procter & Gamble. Donald L. Nofziger and Mary Bailey have received financial support from Procter & Gamble.

Figures

Figure 1.

Urine leak rate by type of change in intent-to-treat population.

Figure 2.

Mean diaper wear time by type of change in intent-to-treat population.

Figure 3.

Topical skin product usage in intent-to-treat population.

Figure 4.

Mean percent of assessments with pressure marks scored at ≥2 in per protocol population.

Figure 5.

Mean percent of assessments with red marking scored at ≥2 in per protocol population.

Figure 6.

Percent of subjects with at least 1 post-baseline rash assessment ≥1.5 in per protocol population.

Figure 7.

Mean percent of post-baseline rash assessments with score ≥1.5 in per protocol population.

Figure 8.

Percent of subjects having consecutive visits with rash score ≥1.5 in per protocol population.