Baldwin 2001.

Study characteristics
Methods	Study design: randomised clinical trial, double‐blinded, parallel‐group comparison trial  Study conducted: no date of recruitment or start/end date of trial reported in the study Treatment arms: 2 (Study C) AD follow‐up: 4 weeks (2 visits every week)
Participants	Randomised: 304 children (evaluated skin erythema and diaper rash in 268 infants over a 4‐week usage period)  Inclusion criteria:  General good health as determined by medical history No evidence of serious or chronic disease upon initial dermatological examination Skin types I to IV on the Fitzpatrick Scale Age range not reported ‐ average participant age: 9.9 months Exclusion criteria:  Severe diaper rash that appeared to require physician treatment
Interventions	Parents of all eligible children were given a 1‐week supply of the control product and were instructed to use only this diaper until the next scheduled visit 6 days later (‘washout’ period). At completion of the ‘washout’ period, 304 children were randomly allocated to 1 of 2 treatment groups after a baseline dermatological examination of the diaper area. Randomisation was by gender and diaper rash grade All parents were instructed to diaper their child exclusively with the product assigned to him/her, and to avoid the use of any ointments, creams, powders, or other diaper rash or skin care products on the diapered area of their children for the entire duration of the study. Parents were allowed to maintain normal bathing and hygiene routines for their children except that they were asked to use a standard disposable infant wipe, which was supplied to them in lieu of their usual wipe or wash cloth for diaper changing needs Parents were instructed to change their child into a clean diaper approximately 2 hours before each subsequent scheduled visit to the clinical site. Children returned to the clinical site twice per week (Monday/Thursday or Tuesday/Friday) over the next 4 weeks, for a total of 8 post‐baseline visits. At each of these visits, the skin in the diaper area of each child was examined for the presence of rash and erythema  Intervention: Group 2 was assigned to use the test diaper   Comparator: Group 1 was assigned to continue on the control product Diaper and wipes: control diaper used was a commercially available, premium quality product containing a super‐absorbent(AGM)/cellulose core and a breathable outer cover, which was obtained directly from our manufacturing lines (Procter & Gamble Co., Cincinnati, OH, USA) The test diaper was identical in every respect to the control except for the inclusion of a top sheet (inner layer) impregnated with a proprietary formulation containing primarily petrolatum, stearyl alcohol, and zinc oxide in combination (ZnO/Pet). The wipes used were Pampers Baby Fresh™, Proctor & Gamble Co.
Outcomes	Severity of diaper dermatitis (skin erythema and rash), scoring given by Table 1 (Baldwin 2001) Adverse events: not reported
Identification	Country: USA Sponsorship source: Hill Top Laboratories (Cincinnati, OH, USA, and Winnipeg, Canada), for its collaboration in the conduct of the clinical studies
Declarations of interest	Not reported
Notes