Phase 3
Completed N=107
Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)
Source: ClinicalTrials.gov NCT01657305 ↗Enrolled (actual)
107
Serious AEs
0.5%
Results posted
Jan 2018
Primary outcomePrimary: Intra-individual Difference in Time to Wound Closure — -1.4 days — p=<0.0001
◆ Published Evidence
Established
64citations · ~7 / year
Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program.
Summary
The main purpose of this phase III clinical trial was to compare intra-individually the efficacy, safety and tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.
Linked Publications
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Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-individual Difference in Time to Wound Closure |
-1.4 | <0.0001 sig |
| SECONDARY Time From Surgery Until Wound Closure is Achieved |
15.5; 17.1 | — |
| SECONDARY Percentage of Participants With Earlier Healing |
61.7; 7.5 | — |
| SECONDARY Percentage of Participants With Wound Closure at Different Time Points |
2.0; 1.0; 25.5; 15.7; 49.0; 37.3 | — |
| SECONDARY Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator |
36.7; 28.1; 60.0; 49.9; 82.2; 74.3 | <0.0001 sig |
| SECONDARY Likert Scale Rating of Efficacy |
15.0; 20.8; 19.6; 15.8; 16.3; 18.0 | — |
| SECONDARY Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively |
36.8; 1.1; 41.4; 31.0; 13.3; 2.4 | — |
| SECONDARY Likert Scale Rating of Tolerability |
6.0; 9.9; 14.4; 11.6; 11.5; 10.0 | — |
| SECONDARY Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration) |
105; 272; 2; 3; 0; 6 | — |
| SECONDARY Pharmacokinetic (PK) Data (Plasma Betulin Concentration) |
2.1; 2.4 | — |
| SECONDARY Frequency of Adverse Events |
17.8; 1.9; 1.9; 2.8; 8.4 | — |
| SECONDARY Severity of Adverse Events |
10.3; 4.7; 4.7; 0.0; 0.0 | — |
| SECONDARY Adverse Events by Relationship to Study Medication |
0.0; 2.8; 0.0; 0.0; 15.9 | — |
Eligibility Criteria
Inclusion Criteria
- Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2 and with a minimum width of 3 cm.
- Patient is able to understand the Informed Consent Form (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 third or fourth 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)).
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.
Data sourced from ClinicalTrials.gov (NCT01657305) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.