Evaluation of a treatment for incontinence associated dermatitis

Not Applicable

Completed

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

Registration Number: ISRCTN74608958

Lead Sponsor: Bracco Healthcare (USA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 32

Inclusion Criteria

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures