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. |
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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 demonstrate that the vehicle for Oleogel-S10 is non-inferior to petrolatum with regards to time to achieve cutaneous healing of mechanically induced partial thickness wounds in healthy volunteers |
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E.2.2 | Secondary objectives of the trial |
To evaluate
- change in cutaneous healing per day of mechanically induced wounds following application of vehicle for Oleogel-S10 and petrolatum
- safety and tolerability of vehicle for Oleogel-S10 and petrolatum as assessed by the incidence, severity, and relatedness of adverse events (AEs) in healthy volunteers with mechanically induced wounds
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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, vasectomy or vasectomised partner, sexual abstinence) during participation in the study (and for at least four weeks thereafter)
4. Skin phototype II to III according to the Fitzpatrick classification
5. Body mass index between 18.5 to 29.9 kg/m2 according to World Health Organization
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 |
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E.4 | Principal exclusion criteria |
1. Pregnant or nursing women
2. SARS-CoV-2 infection is confirmed
3. Positive human immunodeficiency virus, hepatitis B or C serology
4. Known or suspected defect of wound healing
5. Any kind of systemic skin barrier impairment, e.g. atopic dermatitis, psoriasis
6. Scars, tattoos or other skin signs interfering with the study procedures and measurements
7. Sunburn
8. Ultraviolet sessions or sun exposure of the arms planned during the study period
9. Known or suspected hypersensitivity to one of the components of the investigational medicinal products
10. Allergy to Mepilex® Border Lite dressing
11. Any treatment which may affect the blood coagulation and haemostasis (anticoagulant medications, non steroidal anti inflammatory drugs, etc.)
12. Any physical treatment (like laser or surgery) on the arms within the last six months
13. Use of topical or systemic treatments on the investigational areas within four weeks of Day 1 (including but not limited to: topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, vitamin C) that would interfere with assessment and/or investigational treatments
14. Systemic antibiotics, systemic or topical steroids within two weeks of Day 1
15. History or presence of alcohol or drug abuse within the last two years
16. Medical history of skin cancer
17. Diabetes mellitus
18. Any acute or unstable chronic pathology that may interfere with the study conduct, in the opinion of the investigator including found or suspected active SARS-CoV-2 infection
19. Current participation or participation in a clinical study within 30 days of Day 1
20. Subject is in a dependent relationship (e.g. relative or family member) with the investigator, study site’s staff, or sponsor’s staff
21. Subjects who have been placed in an institution through an official or court order |
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E.5 End points |
E.5.1 | Primary end point(s) |
Days until complete healing of mechanically induced wounds in terms of complete re-epithelialisation (assessed by clinical score) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1 to Day 16 and Day 23 |
|
E.5.2 | Secondary end point(s) |
- days until complete healing of mechanically induced wounds according to planimetry
- clinical score per day
- wound surface area in mm2 per day according to planimetry
- incidence, severity, and causality of local AEs
- incidence, severity, and causality of all AEs |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- days until complete healing of mechanically induced wounds according to planimetry:
Day 1, Day 3 and Day 5 to Day 16
- clinical score per day:
Day 1 to Day 16 and Day 23
- wound surface area in mm2 per day according to planimetry:
Day 1, Day 3 and Day 5 to Day 16
- incidence, severity, and causality of local AEs:
Day 1 to Day 23
- incidence, severity, and causality of all AEs:
Day -14 to Day 23 |
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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 | 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 | 2 |
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
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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 | 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 |