Phase 3
N=112
Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12)
Wounds
Bottom Line
View on ClinicalTrials.gov: NCT01807650 ↗Enrolled (actual)
112
Serious AEs
1.8%
Results posted
Jul 2018
Primary outcome: Primary: Intra-individual Difference in Time to Wound Closure — -0.8 days — p==0.0232
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oleogel-S10, non-adhesive wound dressing (Drug); Non-adhesive wound dressing only (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Birken AG
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-individual Difference in Time to Wound Closure |
-0.8 | =0.0232 sig |
| SECONDARY Time From Surgery Until Wound Closure is Achieved |
15.1; 16.0 | — |
| SECONDARY Percentage of Participants With Earlier Healing |
45.5; 30.0 | — |
| SECONDARY Percentage of Participants With Wound Closure at Different Time Points |
2.8; 3.7; 14.8; 8.3; 48.1; 48.1 | — |
| SECONDARY Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator |
27.4; 21.3; 48.6; 42.5; 80.6; 74.9 | =0.0005 sig |
| SECONDARY Likert Scale Rating of Efficacy |
4.7; 13.6; 16.8; 17.8; 17.1; 7.7 | — |
| SECONDARY Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively |
18.9; 1.1; 32.6; 25.3; 13.8; 0.0 | — |
| SECONDARY Likert Scale Rating of Tolerability |
5.4; 8.9; 11.6; 12.5; 13.4; 8.0 | — |
| SECONDARY Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration) |
110; 271; 2; 13; 0; 6 | — |
| SECONDARY Pharmacokinetic (PK) Data (Plasma Betulin Concentration) |
24.0; 10.4 | — |
| SECONDARY Frequency of Adverse Events |
53.6; 4.5; 3.6; 14.3; 24.1; 7.1 | — |
| SECONDARY Severity of Adverse Events |
40.2; 27.7; 7.1; 2.7; 0.0 | — |
| SECONDARY Adverse Events by Relationship to Study Medication |
2.7; 5.4; 8.0; 1.8; 47.3 | — |
Summary
The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.
Eligibility Criteria
Inclusion Criteria
- Participants 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 15 cm2 and with a minimum width of 3 cm.
- Participant was able to understand the Informed Consent Form (ICF) provided and was 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 were closed (but no longer than 28 days after surgery).
- Willing to perform all necessary wound dressing changes at the trial site. Also the participant needed to agree to return to site for 3 and 12 months follow-up visits.
- Women of childbearing potential who were in the period between menarche and menopause needed to apply a 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 needed to 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. Sexually active, non-vasectomized men needed to use a barrier method (condoms) during the treatment phase of this clinical trial.
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 was chronic or currently active and which the Investigator considered would adversely affect the healing of the acute wounds or involved 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 were 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 ICF 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 (NCT01807650). 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.