Conditions: Inherited Epidermolysis Bullosa
Keywords: Epidermolysis bullosa Wound healing Epithelialization
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

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.

Arms:
arm 1: 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'. arm 2: 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'.

Interventions: intervention 1: Oleogel-S10 intervention 2: Mepilex® soft silicone faced polyurethane foam dressing
Intervention descriptions: intervention 1: 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'. intervention 2: 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'.

Protocol document: