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Prevention of neutrophil induced extracellular matrix damage following skin exposure to solar simulating radiation (SSR)

Completed
Conditions
elastosis solaris
sun damaged skin
10014982
Registration Number
NL-OMON31680
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

- adult, men or women, aged 18-55 years.
- healthy white skinned volunteers (skin photo type I-IV).
- volunteers must be willing and able to give written informed consent.

Exclusion Criteria

- contact allergy for any one of the applied topical products
- sunlight allergy.
- tendency to hypertrophic scar or keloid formation.
- history of alcohol or drug abuse.
- treatment with phototherapy or systemic (immunosuppressive) therapy such as oral steroids and cyclosporin A during the study, or within 24 weeks prior to the study.
- chronic treatment with phototherapy (duration > 1 year) and regular exposure of buttock skin to sunlight or artificial UV-sources.
- treatment with oral and local antibiotics.
- treatment with topical steroids or tar in the tested locations during the last 2 weeks.
- clinically relevant cardiovascular, gastrointestinal, liver or renal disease and/or unstable metabolic or endocrine disorders.
- acute or chronic local bacterial, viral or fungal diseases.
- women of childbearing potential not using reliable contraception
- pregnancy or breast feeding.
- psychiatric disease or history of noncompliance which, in the investigator*s assessment would interfere with appropriate protocol treatment and monitoring.
- patients visiting the hospital.
- persons who are situated in a dependant position in relation to the investigators.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>(a) Quantitative comparison of infiltrating neutrophils in treated and<br /><br>untreated skin following exposure to 2 MED SSR using the following markers:<br /><br>neutrophil elastase, CD66b, neutrophil gelatinase-associated lipocalin and<br /><br>human myeloperoxidase.<br /><br>(b) Qualitative study of oxidation reaction products in treated and untreated<br /><br>skin following exposure to 2 MED SSR: thymidine glygol (TG),<br /><br>4-hydroxy-2-nonenal, malondialdehyde, dibromo tyrosine and acrolein.<br /><br>(c) Quantitative comparison of erythema induced in treated and untreated skin<br /><br>following exposure to 18 000 mj/cm².</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>(a) Quantitative comparison of photoaging associated and/or neutrophil<br /><br>associated proteolytic enzymes: MMP-1, MMP-3, MMP-8, MMP-9 and neutrophil<br /><br>elastase in treated and untreated irradiated skin.<br /><br>(b) Qualitative comparison of DNA photoproducts in treated and untreated<br /><br>irradiated skin.<br /><br>(c) Comparison of keratinocyte activation and keratinocyte apoptosis in treated<br /><br>and untreated irradiated skin. </p><br>
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