To investigate the effect of a sunscreen, a topical antioxidant and a topical corticosteroid on erythema, infiltrating neutrophils and oxidative stress following exposure of the skin to SSR.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(a) Quantitative comparison of infiltrating neutrophils in treated and
untreated skin following exposure to 2 MED SSR using the following markers:
neutrophil elastase, CD66b, neutrophil gelatinase-associated lipocalin and
human myeloperoxidase.
(b) Qualitative study of oxidation reaction products in treated and untreated
skin following exposure to 2 MED SSR: thymidine glygol (TG),
4-hydroxy-2-nonenal, malondialdehyde, dibromo tyrosine and acrolein.
(c) Quantitative comparison of erythema induced in treated and untreated skin
following exposure to 18 000 mj/cm².
Secondary outcome
(a) Quantitative comparison of photoaging associated and/or neutrophil
associated proteolytic enzymes: MMP-1, MMP-3, MMP-8, MMP-9 and neutrophil
elastase in treated and untreated irradiated skin.
(b) Qualitative comparison of DNA photoproducts in treated and untreated
irradiated skin.
(c) Comparison of keratinocyte activation and keratinocyte apoptosis in treated
and untreated irradiated skin.
Background summary
Exposure of white skin (skin photo type I-IV) to erythemogenic doses of solar
simulating radiation (SSR) results in an influx of neutrophils. We have
previously shown that neutrophils are a major source of enzymatically active
photoaging-associated proteolytic enzymes. By this capacity they appear to be
important contributors to the process of photoaging of the skin. Preventing
neutrophils from infiltrating the skin following exposure to SSR should limit
the amount of tissue damage. Based on literature data this may be accomplished
by different means: 1) applying sunscreen and thus preventing SSR from
penetrating the skin at all levels 2) using topical antioxidants to scavenge
SSR induced tissue damaging reactive oxygen species 3) applying topical
corticosteroids to suppress the SSR induced inflammatory reaction.
Study objective
To investigate the effect of a sunscreen, a topical antioxidant and a topical
corticosteroid on erythema, infiltrating neutrophils and oxidative stress
following exposure of the skin to SSR.
Study design
Three groups of volunteers will be recruited. In the first group the minimal
erythema dose (MED) of each patient will be determined after which 4 areas of
sun-protected buttock skin will be exposed to 2 MED. One area will be
pre-treated with a sunscreen, another with a topical antioxidant and the third
area with a topical corticosteroid. The fourth area is left untreated. 4 mm
biopsies are taken from each irradiated site after 24 hours. Additionally a
fifth 4 mm control biopsy is taken from unexposed buttock skin. The second
group of volunteers undergo a similar procedure except that here 4 mm biopsies
are taken from each site immediately following SSR exposure. Volunteers may
participate in both groups I and II. In the third group of volunteers
sun-protected buttock skin is pretreated with a series of topical products and
exposed to SSR. Erythema induced is measured and one biopsy is taken per
volunteer.
Intervention
see study design.
Study burden and risks
The lesions resulting from the biopsies may remain visible for a prolonged
period of time as hypopigmented areas. Induced redness of a small area of the
skin following determination of the MED and exposure to SSR should cause no
physical discomfort and may heal with some scaling within days. With no history
of contact allergic reactions single application of a sunscreens, topical
antioxidant and topical corticosteroid should cause no physical discomfort or
have any side-effects. Serious adverse events are highly unlikely. Patients
will receive some financial compensation for their participation.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004616-31-NL |
| CCMO | NL19314.041.07 |