Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare intra-individually the reepithelialization of skin lesion(s) in inherited Epidermolysis bullosa (either 1 wound ≥10 cm2 and ≤200 cm2 in size divided in 2 equal halves or 2 comparable wounds of ≥5 cm2 each) treated with Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only.

Detailed Description
-----------------
This study was designed as an open-label, prospective, controlled, blindly evaluated, monocentric phase II case series documentation in patients with inherited Epidermolysis bullosa (EB). The investigator either identified 1 EB wound ≥10 cm2 and ≤200 cm2 in size and divided it into 2 halves or selected 2 comparable wounds of ≥5 cm2 each. One (half of the) EB wound was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control. Wound dressings were changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'. This was an open-label study. The investigator, the participant, and the sponsor knew the identity of the treatment. Two independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound (half) that were taken before start of treatment, during wound dressing changes and at the end of treatment on Day 14/Day 28.

Official Title
-----------------
Open, Prospective, Controlled Case Series Documentation to Compare Intra-individually the Efficacy and Tolerance of Sericare® Versus Non-adhesive Wound Dressing Alone in Accelerating the Epithelialization of Skin Lesions of Patients With Epidermolysis Bullosa Hereditaria

Conditions
-----------------
Inherited Epidermolysis Bullosa

Intervention / Treatment
-----------------
* Drug: Oleogel-S10
* Device: Mepilex® soft silicone faced polyurethane foam dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 1-95 years Patient and/or his/her legal representative was informed, read and understood the patient information/informed consent form and gave written informed consent Patients with inherited EB with at least 1 skin lesion between 10 cm2 and 200 cm2 (alternatively 2 comparable lesions of at least 5 cm2 each) Patient and/or his/her legal representative was able and willing to follow study procedures and instructions including the following: Application of Oleogel-S10 on (1 half of) the wound at every wound dressing change Regular visits during the treatment period (14 days in 'recent wounds' to 28 days in 'chronic wounds') Negative pregnancy test in women of childbearing potential within 7 days before start of treatment Women of childbearing potential agreed to use an effective method of contraception (Pearl Index < 1, e.g. hormonal contraception including the combined oral contraceptive pill, the transdermal patch, and the contraceptive vaginal ring, intrauterine devices or sterilization) during treatment and for at least 6 months thereafter Men of procreative capacity agreed to use an effective method of contraception during treatment and for at least 6 months thereafter Exclusion Criteria: Systemic treatment with steroids during the last 30 days Uncontrolled diabetes mellitus or diabetic ulcers Diseases or conditions that could, in the opinion of the investigator, interfere with the assessment of safety, tolerance or efficacy Skin disorders adversely affecting wound healing or involving the areas eligible for study treatment Hypersensitivity to the trial medication or surgical dressings to be used Multiple allergic disorders Administration of investigational drugs within 3 months before screening Investigations or changes in management for an existing medical condition Low probability to complete the study per protocol for whatever reason

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oleogel-S10<br>The eligible wound (half) was topically treated with Oleogel-S10 and covered with a non-adhesive wound dressing (Mepilex®) on Day 0. Wound dressings were changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'. | Drug: Oleogel-S10<br>* 1 cm or 125 µL or 115 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.<br>* Other names: Sericare®;Device: Mepilex® soft silicone faced polyurethane foam dressing<br>* Mepilex® soft silicone faced polyurethane foam dressing was changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.<br>* Other names: Cutaneous patch;|
| Other: Non-adhesive wound dressing<br>Mepilex® soft silicone faced polyurethane foam dressing was used as non-active comparator. The eligible wound (half) was covered with Mepilex® as control on Day 0. Wound dressings were changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'. | Device: Mepilex® soft silicone faced polyurethane foam dressing<br>* Mepilex® soft silicone faced polyurethane foam dressing was changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.<br>* Other names: Cutaneous patch;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds' | The primary end point was the progress of reepithelialization from baseline to either Day 14 ('recent wounds') or Day 28 ('chronic wounds') of the EB wound (half) treated with Oleogel-S10 and non-adhesive wound dressing (Mepilex®) intra-individually compared to the other wound (half) covered with non-adhesive wound dressing only (intra-individual comparison). Two independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound (half) that were taken before start of treatment, during wound dressing changes and at the end of treatment on Day 14/Day 28. They evaluated each series and decided whether 1 wound (half) reepithelialized faster than the other ('winner'), or whether there was no difference in reepithelialization. | 14 days for 'recent wounds', 28 days for 'chronic wounds' | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Wound Epithelialization at Day 7±1 | The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 7±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg. | Day 7±1 | 
| Percentage of Wound Epithelialization at Day 14±1 | The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 14±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg. | Day 14±1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidermolysis bullosa, Wound healing, Epithelialization