E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Not applicable, as healthy volunteers will be recruited, who will receive mechanically induced partial thickness wounds. |
|
E.1.1.1 | Medical condition in easily understood language |
Not applicable, as healthy volunteers will be recruited, who will receive superficial skin wounds. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
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 |
To describe and to measure cutaneous healing of mechanically induced wounds with application of vehicle of Oleogel S10, petrolatum, and no treatment in healthy volunteers in a wound healing model of mechanically induced wounds. |
|
E.2.2 | Secondary objectives of the trial |
To describe the safety, tolerability, and transepidermal water loss (TEWL) in healthy volunteers treated with the vehicle gel and petrolatum compared to no treatment in a wound healing model of mechanically induced wounds. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Adult healthy volunteers aged 18 to 45 years
2. Male or female
3. Sexually active females of childbearing potential must be willing to use an effective form of birth control with failure rates <1% per year (e.g., implant, injectable, combined oral contraceptive, intrauterine contraceptive device, sexual abstinence, vasectomy or vasectomised partner) during participation in the study (and at least 4 weeks thereafter)
4. Skin type II to III according to the Fitzpatrick classification (Fitzpatrick 1988)
5. BMI between 18.5 to 29.99 kg/m2 according to WHO
6. Non-smoker
7. Subject has been informed, has read and understood the information/informed consent form, and has given written informed consent
8. Subject must be able and willing to follow study procedures and instructions |
|
E.4 | Principal exclusion criteria |
1. Pregnant or nursing women
2. Positive HIV, hepatitis B or C serology
3. Known or suspected defect of wound healing
4. Any kind of systemic skin barrier impairment, e.g. atopic dermatitis, psoriasis
5. Scars, tattoos or other skin signs interfering with the study procedures and measurements
6. Sunburn
7. UV sessions or sun exposure of the arms planned during the study period
8. Known or suspected hypersensitivity to one of the components of the investigational medicinal products
9. Allergy to Mepilex® dressing
10. Any treatment which may affect the blood coagulation and haemostasis (anticoagulant medications, NSAID, etc.)
11. Any physical treatment (like laser or surgery) on the arms within the last 6 months
12. Use of topical or systemic treatments on the investigational areas within the 4 past weeks (including but not limited to: topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, vitamin C) that would interfere with assessment and/or investigational treatments
13. Systemic antibiotics, systemic or topical steroids within 2 weeks of Day 1
14. History or presence of alcohol or drug abuse within the last 2 years
15. Medical history of skin cancer
16. Diabetes mellitus
17. Any acute or unstable chronic pathology that may interfere with the study conduct, in the opinion of the Investigator
18. Current participation or participation in a clinical study within 30 days of Day 1 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Because of the exploratory nature of the study, a distinction between primary and secondary endpoints will not be made.
• Cutaneous wound healing: time to complete healing in days
• Cutaneous wound healing: wound surface area per day in mm2
• Cutaneous wound healing: wound surface area per day according to clinical score
• Transepidermal water loss per day in g/h/m2
• Adverse events |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Cutaneous wound healing (Clinical observation by trained Investigator & Six-category clinical score):
• Day 1 through Day 21
• Day 23
• Day 28
Cutaneous wound healing (Photo documentation with FotoFinder & Measurement of wound surface area using computerized image analysis (planimetry)):
• Every 2 days (i.e., Day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and Day 23)
• Day 28
Trans-epidermal water loss:
• Every 2 days (i.e., Day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and Day 23)
• Day 28
Local tolerance:
At all visits
Adverse events:
At all visits |
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E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |