The strength of the association between diaper dermatitis and measurements of skin wetness and skin pH was evaluated by statistical analysis of four diaper trials involving 1601 infants. Although the strength of the association between skin wetness and diaper dermatitis was greater than that between skin pH and diaper dermatitis, increases in wetness and pH were both significantly associated with elevated mean grades for diaper dermatitis. The skin environment least likely to be associated with diaper dermatitis is one in which increases in both skin wetness and skin pH are minimized.

Background: Diaper dermatitis is a common childhood affliction. Aiming to help reduce the prevalence of this problem, we have developed a novel diaper to deliver to the skin dermatological formulations intended to help protect the skin from overhydration and irritation. Objective: To determine the clinical benefits of a novel disposable diaper designed to deliver a petrolatum-based formulation continuously to the skin during use. Methods: Two independent, blinded, randomized clinical trials were conducted, involving an aggregate total of 391 children, 8–24 months of age. All comparisons were done versus a control diaper, identical to the test product except for the absence of the petrolatum formulation. The studies determined the effects of the novel diaper on skin erythema and diaper rash. Results: Use of the formulation-treated diaper was associated with significant reductions in severity of erythema and diaper rash compared to the control product. Conclusions: The results demonstrated the clinical benefits associated with continuous topical administration of a petrolatum-based formulation by this novel diaper. We anticipate that this advance in diaper design will contribute significantly to further reduce the prevalence and severity of irritant contact dermatitis in the diaper area.

Background: Cutaneous problems are commonly associated with the use of diapers. Aiming to help reduce them, we have explored the use of the inner layer of diapers as a means to deliver to the skin dermatological formulations intended to help protect it from overhydration and irritation. Objective: To determine the feasibility of using the inner layer of the diaper as a vehicle for topical delivery of a petrolatum-based formulation and to determine its impact on skin surface microtopography. Methods: Two independent, blinded, randomized clinical trials were conducted, on children 16–24 months of age. All comparisons were done versus a control diaper, identical to the test product except for the absence of the petrolatum formulation. The studies determined the effects of the novel diaper on transfer of formulation to the skin and skin surface microtopography. Results: During normal diaper use, formulation transfer from the diaper to the skin occurred in a cumulative, time-dependent manner and use of the formulation-treated diaper was associated with significant reductions in skin surface roughness compared to the control diaper. Conclusions: The results demonstrated the feasibility and skin surface benefits associated with continuous topical administration of a petrolatum-based formulation by this novel diaper. This unprecedented dosimetric approach offers new avenues to reduce further the dermatological problems commonly associated with diaper use.

A trial to detect a 50% preventive effect on Stage 1 and 2 pressure ulcers would require that 167 subjects be monitored for 60 days. The transient nature of the skin effects require that skin be monitored at least once a week. Because blanchable erythema is so prevalent and appears to be associated with more severe skin conditions, it would make an excellent marker for beginning to assess the potential preventive effects of various interventions on the incidence of pressure ulcers and other related skin disorders in incontinent patients. It is likely that the back area peripheral to the urethra and rectum would experience the greatest benefit from an intervention trial to reduce moisture caused by incontinence.

Infants and toddlers in day-care centers have a relatively high frequency of diarrhea and/or oral antibiotic use, and may be at increased risk of developing diaper dermatitis when diapered. A six-month, prospective, double-blind study was conducted in day-care centers in Houston, Texas, to determine the frequency of diarrhea, antibiotic use, and diaper dermatitis in infants and toddlers wearing conventional (cellulose-only core) disposable diapers or disposable diapers with a core of absorbent gelling material (AGM) and cellulose. A questionnaire was administered weekly to the day-care staff to gather health information, and weekly visual examinations were made of children for diaper dermatitis. The frequency of diarrhea was 1.9 episodes per child-year and that of antibiotic use was 3.3 courses per child-year. Infants diapered in disposable diapers with AGM had a significantly (P 0.032) lower mean grade of diaper dermatitis during diarrhea episodes and a lower (P 0.054) mean grade during antibiotic use, compared to those diapered in conventional disposable diapers. There was no significant difference between groups with regard to isolation of Staphylococcus aureus or Candida albicans from superficial skin cultures of the diapered area. The results indicate that diarrhea and antibiotic use occur frequently in children in day-care centers, and that the severity of diaper dermatitis is less in children wearing AGM disposable diapers than those wearing conventional disposable diapers in that setting.