E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
sunburn (erythema solaris), photoaging (elastosis solaris) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000705 |
E.1.2 | Term | Acute dermatitis due to solar radiation |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
(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.
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E.2.2 | Secondary objectives of the trial |
(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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The cosmeceuticals vision SPF 28 (sunscreen) and vitamin E 6% cream |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial ends when all subjects (n=12) have undergone the experimental procedures. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |