Prevention of neutrophil induced extracellular matrix damage following skin exposure to solar simulating radiation (SSR) - Prevphotoag
- Conditions
- sunburn (erythema solaris), photoaging (elastosis solaris)MedDRA version: 9.1Level: LLTClassification code 10000705Term: Acute dermatitis due to solar radiation
- Registration Number
- EUCTR2007-004616-31-NL
- Lead Sponsor
- niversitair Medisch Cemtrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- adult, male or female, aged 18-55 years.
- healthy white skinned volunteers (skin photo type I-III).
- volunteers must be willing and able to give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method