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Evaluation of a treatment for incontinence associated dermatitis

Assessment of a topical skin protectant (barrier cream) for the prevention and treatment of incontinence-associated dermatitis (IAD).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74608958
Enrollment
32
Registered
2012-05-04
Start date
2012-09-03
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence-associated dermatitis Skin and Connective Tissue Diseases Unspecified contact dermatitis due to other agents

Interventions

The project is organised into four elements. Work Package 1 relates to the ethics application. Initial work with human volunteers (Work Package 2) will establish the actual thickness of RD1433 require
Vaseline™) within Work Package 4. This experimental approach will enable an efficacy assessment for both prevention and treatment strategies. The corresponding data would be collated into a final rep

Sponsors

Bracco Healthcare (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >17 years 2. Generally healthy 3. Willing to attend up to three, five day sessions

Exclusion criteria

Exclusion criteria: 1. Dark-skinned volunteers. (This is because darker skin may affect some of the measurements we intend to make, as our instruments rely on being able to detect changes in skin colour and blood flow. The presence of melanin (the substance responsible for darkening the skin) reduces the sensitivity of our equipment. This will not affect the outcome of our study ? if the treatment is successful, it will work on all skin types.) 2. Pre-existing skin disease such as eczema, dermatitis or skin allergy 3. Concurrent use of aspirin, paracetamol or any other anti-inflammatory drugs

Design outcomes

Primary

MeasureTime frame
1. Significant reduction in vascular perfusion (Laser Doppler imaging; arbitrary perfusion units) 2. Significant reduction in erythema (skin reflectance spectroscopy; CIELAB ?a*? parameter) 3. Significant reduction in transepidermal water loss (evaporimetry; mg/cm2/h) 4. Significant reduction in skin surface temperature (infrared imaging; °C)

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026