E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epidermal abrasive wounds |
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MedDRA Classification |
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 |
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E.2.2 | Secondary objectives of the trial |
- Re-epithelization day 2, 3, 4, 6, 7, 8, 9, 10, and 15 - assessment of cosmetic outcome/acceptance day 36 - documentation and analysis of safety parameters |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female caucasian • Age 18 to 45 • Skin type I to IV • Willingness to actively participate in the study and to comply with the study procedures as defined in the study protocol • Signed written informed consent • Negative urine pregnancy test (in female subjects of childbearing potential) • For female subjects of childbearing potential: use of a reliable contraceptive method (e.g. contraceptive pills, intrauterine contraceptive device, implants). |
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E.4 | Principal exclusion criteria |
• Active skin disease, moles, tattoos, strong pigmentation at the test area or scars in the test area that would influence the visual scoring • History of keloids and hypertrophic scars • History of plaster sensitivity • Intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants, and antihistamines) within 30 days before day 1 as well as during the study. • Concomitant therapy with substances affecting blood coagulation (e.g. acetylsalicylic acid, anticoagulants, diuretics) within up to 14 days prior to the start of the study as well as during the study • Any condition or treatment (within 14 days prior to the start as well as during the study) which might influence the study (e.g. diabetes, dysfunction of blood clotting) • Change of hormonal contraception within 3 months prior to enrolment and during the study • Application of any topical treatment (e.g. moisturizers, sun protection) at the test areas during the conduct of the study (until day 36) • Intensive UV-light exposure within two weeks before the beginning as well as during the study • Removal of axillary lymph nodes • Allergy to the ingredients of the test product • Pregnancy or lactation • Any illness on account of which the subject should not participate in the study in the opinion of the investigator • Any history of drug addiction or alcoholism in the past 3 years • Infectious diseases (e.g. hepatitis or AIDS) • Participation in a clinical trial within the last 30 days prior to enrolment |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | No |
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
|
The end of the trial is defined as the last visit of the last subject. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 36 |
E.8.9.2 | In all countries concerned by the trial days | 36 |