Clinical trial NCT01807650: Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12)
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 Wound Healing of Split-Thickness Skin Graft Donor Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wounds
Keywords: Split-Thickness Skin Graft (STSG) donor site
Split-thickness skin graft
STSG
Wound healing
Skin grafting
Superficial wound
Partial-thickness wound
Time to wound closure
Lead sponsor: Amryt Pharma
Sponsor class: INDUSTRY
First posted: 2013-03-08
Enrollment: 112
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 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.

Detailed description: Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in participants with skin lesions. Especially the results in a previous study with STSG donor sites suggested that Oleogel-S10 should be efficacious and safe in the treatment of superficial wounds.

The present phase III clinical trial in STSG donor sites was initiated to demonstrate wound healing progress, i.e., the time to healing and the grade of epithelialization of the wound.

In this study, STSG donor sites were separated into 2 wound halves. Randomly assigned, 1 wound half was treated with Oleogel-S10 and non-adhesive wound dressing, the other wound half with non-adhesive wound dressing only (standard of care).

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

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.

Primary outcomes:
measure: Intra-individual Difference in Time to Wound Closure
timeFrame: 2 to 4 weeks
Secondary outcomes:
measure: Time From Surgery Until Wound Closure is Achieved
timeFrame: 2 to 4 weeks
measure: Percentage of Participants With Earlier Healing
timeFrame: 2 to 4 weeks
measure: Percentage of Participants With Wound Closure at Different Time Points
timeFrame: 2 to 4 weeks
measure: Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
timeFrame: 2 to 4 weeks
measure: Likert Scale Rating of Efficacy
timeFrame: 2 to 4 weeks
measure: Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively
timeFrame: 3 months and 12 months
measure: Likert Scale Rating of Tolerability
timeFrame: 2 to 4 weeks
measure: Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)
timeFrame: up to 4 weeks
measure: Pharmacokinetic (PK) Data (Plasma Betulin Concentration)
timeFrame: up to 4 weeks
measure: Frequency of Adverse Events
timeFrame: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
measure: Severity of Adverse Events
timeFrame: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
measure: Adverse Events by Relationship to Study Medication
timeFrame: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Marseille
country: France
facility: Hôpital de la Conception
city: Nantes
country: France
facility: CHU de Nantes
city: Athens
country: Greece
facility: KAT General Hospital of Attica
city: Athens
country: Greece
facility: National University, "Andreas Syggros" Skin & Venereal Diseases Hospital
city: Thessaloniki
country: Greece
facility: Aristotle University General Hospital
city: Riga
country: Latvia
facility: Riga East University Hospital, Microsurgery Center
city: Riga
country: Latvia
facility: Riga East University Hospital, State Burn Center
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario de Getafe
city: Valencia
country: Spain
facility: Hopital Universitari i Politecnic La Fe
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Ortega
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Universitari Vall d´Hebron, Barcelona, Spain
name: Juan Pedro Barret Nerin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barret JP, Podmelle F, Lipovy B, Rennekampff HO, Schumann H, Schwieger-Briel A, Zahn TR, Metelmann HR; BSH-12 and BSG-12 study groups. Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program. Burns. 2017 Sep;43(6):1284-1294. doi: 10.1016/j.burns.2017.03.005. Epub 2017 Apr 8.