E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Split-Thickness Skin Graft Donor Sites |
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E.1.1.1 | Medical condition in easily understood language |
Wounds resulting from skin areas from which the upper skin layers have been removed in order to be used as skin transplant to cover injuries from the same patient |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041667 |
E.1.2 | Term | Split thickness skin graft |
E.1.2 | System Organ Class | 100000004865 |
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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 |
To compare intra-individually the efficacy and tolerance of Oleogel-S10 versus non-adhesive wound dressing alone in
accelerating the wound healing of Split-Thickness Skin Graft Donor Sites. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients at least 18 years old who have provided written informed consent
• Presenting a split-thickness skin graft donor site wound with a minimum size of 20 cm2 and with a minimum width of 3 cm.
• Patient is able to understand the ICF provided and is prepared to comply with all study requirements, including the following: Visiting the trial site for wound dressing change and photo documentation every second to third day until both wound halves are closed (but no longer than 28 days after surgery).
• Willing to perform all necessary wound dressing changes at the trial site. Also the patient needs to agree to return to site for 3 and 12 months follow-up visits.
• Women of childbearing potential must apply highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner)). Birth control method must have been applied for at least 1 monthly cycle prior to first administration of study drug, be maintained during the study treatment phase and continued for at least 30 days after the last administration of study drug. |
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E.4 | Principal exclusion criteria |
• Diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety or efficacy.
• A skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
• A history of clinically significant hypersensitivity to any of the drugs, surgical dressings or excipients to be used in this trial.
• Known multiple allergic disorders.
• Taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
• Pregnant or breast feeding women are not allowed to participate in the study.
• Inappropriate to participate in the study, for any reason, in the opinion of the investigator.
• Mental incapacity or language barriers precluding adequate understanding the Informed consent form or co-operation or willingness to follow study procedures.
• Previous participation in this study.
• Employee at the investigational site, relative or spouse of the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
Intra-individual difference in time to wound closure (at least 95% epithelialisation) between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing alone, based on blinded photo evaluation by three independent, blinded experts.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At every wound dressing change (at least every second or third day until full wound closure is achieved; no longer than 28 days after surgery) |
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E.5.2 | Secondary end point(s) |
A) Intra-individual difference in time to wound closure (at least 95% epithelialisation) between wound halves either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing alone, separately for each of the three independent, blinded experts.
B) Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing alone.
C) Percentage of patients with earlier healing of wound area treated with Oleogel-S10 compared to non-adhesive wound dressing alone.
D) Percentage of patients with wound closure at different time points.
E) Percentage of wound epithelialization at different time points as assessed by the Investigator.
F) Assessment of efficacy (evaluated by both the investigators and patients).
G) Cosmetic outcome after 3 and 12 months after surgery with regard to texture, redness, growth of hair, and pigmentation, based on blinded photo evaluation.
H) Assessment of tolerance (evaluated by both the investigators and patients).
I) PK data: Systemic presence/concentration of betulin in blood plasma samples.
J) Assessment of adverse events.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
A) to E), J):
At every wound dressing change (at least every second or third day until full wound closure is achieved; no longer than 28 days after surgery)
F):
Days 7, 14, 21, 28 (each +/- 1 day); only if wound closure did not occur before
G):
3 and 12 months after surgery
H):
Days 7, 14, 21, 28 (each +/- 1 day); only if wound closure did not occur before
I):
Days 7, 14, 21, 28 (each +/- 1 day); only if wound closure did not occur before
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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 | Yes |
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) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
intra-individual comparison of two treatment regimes |
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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 |
Comparison to no other treatment than non-adhesive wound dressing |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |