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Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds

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ClinicalTrials.gov Identifier: NCT01657292
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Amryt Pharma ( Birken AG )

Tracking Information
First Submitted Date  ICMJE July 29, 2012
First Posted Date  ICMJE August 6, 2012
Results First Submitted Date  ICMJE July 31, 2015
Results First Posted Date  ICMJE September 28, 2015
Last Update Posted Date September 28, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care [ Time Frame: 2 to 3 weeks ]
Photo-based evaluation by independent experts blinded to the treatment regime.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01657292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
  • Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care [ Time Frame: 2 to 3 weeks ]
  • Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care [ Time Frame: 2 to 3 weeks ]
  • Percentage of Patients With Wound Closure at Different Time Points [ Time Frame: 2 to 3 weeks ]
  • Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator [ Time Frame: 2 to 3 weeks ]
  • Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients) [ Time Frame: 2 to 3 weeks ]
    By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to grade the efficacy of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale
  • 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 [ Time Frame: 3 and 12 months ]
  • Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients) [ Time Frame: 2 to 3 weeks ]
    By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to provide their opinion on the tolerance of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale
  • PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples [ Time Frame: 2 to 3 weeks ]
  • Microbial Colonization of the Wound Halves [ Time Frame: 2 to 3 weeks ]
  • Assessment of Adverse Events [ Time Frame: 2 to 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burns
Intervention  ICMJE
  • Drug: Oleogel-S10 ointment
    Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing
  • Device: Octenilin® wound gel
    Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing
    Other Name: Contains Octenidine
Study Arms  ICMJE
  • Experimental: Oleogel-S10 ointment
    Intra-individual comparison. Oleogel-S10 ointment is administered to one randomly assigned wound half.
    Interventions:
    • Drug: Oleogel-S10 ointment
    • Device: Octenilin® wound gel
  • Octenilin® wound gel
    Intraindividual comparison: The other wound half receives disinfectant Octenilin® wound gel.
    Interventions:
    • Drug: Oleogel-S10 ointment
    • Device: Octenilin® wound gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2015)
61
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2012)
60
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01657292
Other Study ID Numbers  ICMJE BBW-11
2012-000362-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amryt Pharma ( Birken AG )
Study Sponsor  ICMJE Birken AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bernd Hartmann, Dr. Trauma Hospital Berlin, Warener Str. 7, 12683 Berlin, Germany
PRS Account Amryt Pharma
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP