Clinical trial NCT01657292: Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
Official title: Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Standard of Care in Accelerating the Healing of Grade 2a Partial-Thickness Burn Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burns
Keywords: Wound healing
Burn wound
Superficial partial-thickness burn wound
Grade 2a burn wounds
Time to wound closure
Lead sponsor: Amryt Pharma
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.

Detailed description: Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in patients with skin lesions. Especially the results in the split-thickness skin graft donor site, which is regarded as an excellent model for any kind of superficial wounds in human skin, suggest that Oleogel-S10 should be efficacious and safe in treatment of grade 2a burns.

The present Phase III clinical trial in grade 2a burns is initiated in order to measure the wound healing progress applying objective methods, i.e., the time to healing and the grade of epithelialization of the wound.

In this study, grade 2a burn wounds are separated into two halves: Following wound cleaning and disinfection, wounds are separated into two wound halves. Randomly assigned, one wound half receives Oleogel-S10 ointment, the other wound half standard of care treatment.

Wound healing progress is documented by photos which are assessed by expert reviewers blinded to the treatment of the wound halves.

Eligibility 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
* 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:

* 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.
* 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 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

Primary outcomes:
measure: Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care
timeFrame: 2 to 3 weeks
Secondary outcomes:
measure: Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care
timeFrame: 2 to 3 weeks
measure: Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care
timeFrame: 2 to 3 weeks
measure: Percentage of Patients With Wound Closure at Different Time Points
timeFrame: 2 to 3 weeks
measure: Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
timeFrame: 2 to 3 weeks
measure: Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)
timeFrame: 2 to 3 weeks
measure: 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
timeFrame: 3 and 12 months
measure: Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)
timeFrame: 2 to 3 weeks
measure: PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples
timeFrame: 2 to 3 weeks
measure: Microbial Colonization of the Wound Halves
timeFrame: 2 to 3 weeks
measure: Assessment of Adverse Events
timeFrame: 2 to 3 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Uppsala
country: Sweden
facility: University Hospital
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital
Study officials:
affiliation: Trauma Hospital Berlin, Warener Str. 7, 12683 Berlin, Germany
name: Bernd Hartmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References: