sunburn (erythema solaris), photoaging (elastosis solaris) MedDRA version: 9.1 Level: LLT Classification code 10000705 Term: Acute dermatitis due to solar radiation
Conditions
Interventions
Trade Name: Betnelan hydrofiele creme 1mg/g
Product Name: betamethasone 0.1% cream
Pharmaceutical Form: Cream
Sponsors
Universitair Medisch Cemtrum Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (a) To determine the effect of sunscreen (vision SPF 28), topical vitamin E (vitamin E 6% cream) and topical corticosteroid (betamethasone 0.1% cream) on the infiltration of neutrophils following exposure to SSR. (b) To determine the effect of sunscreen (vision SPF 28), topical vitamin E (vitamin E 6% cream) and topical corticosteroid (betamethasone 0.1% cream) on oxidative reaction products following exposure to SSR. ;Secondary Objective: (a) To specifically look at photoaging associated and/or neutrophil associated proteolytic enzymes: MMP-1, MMP-3, MMP-8, MMP-9 and neutrophil elastase. (b) To determine the distribution of DNA photoproducts in treated and un-treated skin. (c) To look specifically at keratinocyte activation and apoptosis in treated and un-treated skin. ;Primary end point(s): 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 un-treated skin following exposure to 2 MED SSR: thymidine glygol (TG), 4-hydroxy-2-nonenal, malondialdehyde, dibromo tyrosine and acrolein. | — |
Countries
Netherlands
Outcome results
None listed