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Prevention of Incontinence-associated Dermatitis

NCT05403762 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-03-18

Study results available
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Summary

Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged direct contact of the skin with urine and/or stool. Elderly and care-dependent people are often affected by this type of inflammation. Gentle skin cleansing and the use of skin protection products are recommended. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. There is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory trial in elderly nursing home residents and geriatric patients will be conducted.

Conditions

  • Incontinence-associated Dermatitis

Interventions

OTHER

ESENTA™ Skin Barrier Spray (ConvaTec, UK)

The skin protectant will be applied on clean and dry skin exposed to urine and stool. After application, the solvent evaporates leaving a silicone film on the skin surface.

OTHER

Hydrophobes Basisgel DAC

The skin protectant will be applied on clean and dry skin. It contains 95% paraffin oil and creates a hydrophobic layer on the skin surface.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Jan Kottner, Prof. · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-19
Primary Completion
2025-02-06
Completion
2025-02-06

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05403762 on ClinicalTrials.gov