Superficial partial-thickness (grade 2a) burn wounds MedDRA version: 14.1 Level: PT Classification code 10006802 Term: Burns second degree System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: Oleogel-S10
Pharmaceutical Form: Ointment
INN or Proposed INN: Dry extract from Betulae cortex (Birch cork) (5-10 : 1), quantification: 72-88% Betulin, extraction solvent: n-Heptane 95%
Sponsors
Birken AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients at least 18 years old who have provided written informed consent. • Presenting with acute grade 2a burn wounds (as graded by an expert surgeon assisted by LDI or a multispectral imaging system) within 48 hours after injury. • Burn wound caused by fire burn, heat burn or scalding. • Burn patients with grade 2a burn wounds between 80 cm2 and less than 25% of their TBSA (alternatively, 2 comparable wounds with size more than 40 cm2 each and less than 12.5% of the TBSA each are allowed). • Patient is able to understand the Informed Consent Form provided and is prepared to comply with all study requirements, including the following: Visiting the trial site for wound dressing changes at least every second day (if patient is not hospitalized) and photo documentation until full wound closure or until the investigator decides to change medication and/or treatment after day 21 after start of treatment; visiting the trial site for two follow up visits after 3 and 12 months. • 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)). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Suffering from chemical burns, or electrical burns or sunburns. • Having already received treatment for their burn with silver sulfadiazine (obscures photographic wound evaluation). • Positive blood culture after the burn. • Diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerance 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 or surgical dressings 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. • Inappropriate to participate in the study, for any reason, in the opinion of the Investigator. • Pregnant or breast feeding women are not allowed to participate in the study. • Mental incapacity or language barriers precluding adequate understanding 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare intra-individually the efficacy and tolerance of Oleogel-S10 with fatty gauze as wound dressing versus Standard of Care (defined as octenilin® Wound Gel) with fatty gauze as wound dressing in accelerating the healing of grade 2a burns. ;Secondary Objective: not applicable;Primary end point(s): Percentage of patients with earlier healing (at least 95% epithelialization) of the wound half treated with Oleogel S10 compared to standard of care (octenilin® Wound Gel), as evaluated by the majority decision of three independent, blinded experts. ;Timepoint(s) of evaluation of this end point: At every wound dressing change (at least every second day until full wound closure is achieved) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints A. Percentage of patients with earlier healing of wound half treated with Oleogel-S10 compared to octenilin® Wound Gel, evaluated separately for each of the three independent, blinded experts B. Percentage of patients with earlier healing of wound half treated with Oleogel-S10 compared to all other patients (earlier healing of wound half treated with octenilin® Wound Gel or no difference between treatment regimes) C. Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and fatty gauze as wound dressing or treated with octenilin® Wound Gel and fatty gauze as wound dressing D. Time from study start after burn accident until wound closure is achieved separately for wound halves treated with Oleogel-S10 and fatty gauze as wound dressing vs. octenilin® Wound Gel and fatty gauze as wound dressing E. Percentage of patients with wound closure at different time points F. Percentage of wound epithelialization at different time points as assessed by the Investigator G. Assessment of efficacy (evaluated by both the Investigators and patients) H. Cosmetic outcome after 3 and 12 months after burn accident, in relation to texture, redness, growth of hair and pigmentation, based on blinded photo evaluation Safety Endpoints I. Assessment of tolerance (evaluated by both the Investigators and patients) J. PK data: Systemic presence/concentration of betulin in blood plasma samples K. Microbial colonization L. Assessment of adverse events ;Timepoint(s) of evaluation of this end point: A) to F), J): At every wound dressing change (at least every second day until full wound closure is achieved) G), I), K): At Days 7 (+/- 1 day), 14 (+/- 1 day), 21 / end of treatment H): After 3 and 12 months J): At Days 0, 7 (+/- 1 day), 14 (+/- 1 day), 21 / end of treatment L): At Day 0, at every wound dressing change, at Day 21 / end of treatment | — |
Countries
Germany, Sweden, Switzerland, United Kingdom
Contacts
Public ContactBusiness Unit Pharma
Birken AG
Outcome results
None listed