Further determining the possible association of skin irritation threshold and hypertrophic scar formatio
- Conditions
- hypertrophic scarsskin allergic reaction1000170810014982
- Registration Number
- NL-OMON51239
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 62
Healthy human female volunteers who are prior to undergoing reduction
mammoplasties, are 18 years or older and legally competent.
* Fitzpatrick photo skin type IV or higher
* Skin disease, e.g. psoriasis, pemphigus vulgaris etc.
* Skin lesions, tattoos or substantial hair growth on the patch test site
* Pregnancy or lactation during the patch test
* Topical immunosuppressive treatment of the upper arm in the last 7 days
before the patch test
* Application of skin lotions or ointments on the upper arm in the last 6 weeks
before the patch test
* Abundant exposure of the upper arm to UVR during the patch test
* Systemic antibiotic treatment in the last 2 weeks before the patch test
* Systemic immunosuppressive treatment
* Immunological disorders: infectious disease, immune deficiencies, auto-immune
disorders
* Alcohol or drug abuse
* Smoking
* ASA classification 3 or higher
* Simultaneous participation in another clinical study that could interfere
with the outcome of this study
* Performing physical activities which cause heavy sweating, sauna, swimming or
extreme showers or baths during the patch test
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints:<br /><br>Primary parameter: IT as determined by visual irritation grading scale after<br /><br>SLS patch test.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters: response of PBMC*s to stimulation with LPS, and cytokines<br /><br>in serum. </p><br>