Evaluation of a new topical skin protectant (RD1433) for the prevention and treatment of incontinence-associated dermatitis

Abstract

Context Incontinence-associated dermatitis (IAD) is a type of moisture-associated dermatitis caused by repeated skin exposure to urine or stool. A product that could mitigate such symptoms would have a significant impact on cost of care and patients’ quality of life.

Objective This study compared the clinical efficacy of RD1433 and a comparator product (Vaseline®) in preventing and treating experimental IAD skin lesions.

Materials and methods For the “prevention” part of the study, skin sites in eight human volunteers were treated daily for 5 d with either RD1433 or Vaseline® immediately prior to synthetic urine exposure. In the “treatment” part, exposure to synthetic urine was substituted for Vaseline® or RD1433 application on the first 2 d to promote the development of skin lesions prior to the application of the products from day three. Product efficacy was quantified by visual scoring and an array of biophysical instruments.

Results Both RD1433 and Vaseline® significantly reduced lesion progression when applied as a prophylactic. When applied as a treatment (following establishment of skin lesions), RD1433 demonstrated a statistically significant improvement in several measures of skin function whereas there was no statistically significant improvement following treatment with Vaseline®.

Conclusions The findings of this study suggest that RD1433 may be superior to Vaseline® in the prevention and treatment of experimental IAD lesions. Clearly, further work is required to establish the efficacy of RD1433 with patients in a clinical environment.

Keywords:

• Clinical study
• erythema
• human volunteer
• laser Doppler imaging
• synthetic urine
• topical treatment
• transepidermal water loss
• white petroleum jelly

Acknowledgements

Firstly, the authors would like to personally thank all the volunteers for their participation in this study. The authors also wish to thank Professor Fabrizio Schifano and Professor Ken Farrington for their clinical support and Dr Richard Amlôt, Microbial Risk Assessment & Behavioural Science, Emergency Response Department, Public Health England, Porton Down, for performing the statistical analysis.

Declaration of interest

None of the authors has any conflicts of interest with regard to this study.

This study was funded by Bracco Diagnostics Inc. (Princeton, NJ).