E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Biopsy wounds on healthy volunteers |
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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 |
The objective of this study is to analyse the efficacy of pantothenate on wound healing by investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level involved in skin proliferation after wounding of the skin and three different numbers of applications. |
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E.2.2 | Secondary objectives of the trial | |
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 •Willingness to avoid intensive sunlight exposure two weeks before the start of the study and at least 2 months after removal of the stitches •Signed written informed consent •Negative urine pregnancy test (in female subjects of childbearing potential) •reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner)
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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 •Frequent visits of tanning booths •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 •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 •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing •Any history of drug addiction or alcoholism in the past 3 years •Infectious diseases (e.g. hepatitis or AIDS) •If in the opinion of the investigator the subject should not participate in the study for any reason •Participation in a clinical trial within the last 30 days prior to enrolment •Employees of the study sites or of the Sponsors company
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E.5 End points |
E.5.1 | Primary end point(s) |
The investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level involved in skin proliferation after wounding of the skin and three different numbers of applications. In the gene-level expression analysis, multiple probes on different exons are summarized into an expression value of all transcripts from the same gene. The major focus of the investigation will be on proliferation stimulating genes, on anti-apoptotic genes and genes for the regulation of anti-inflammatory mediators. |
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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
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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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 7 |