Trial Outcomes & Findings for Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10) (NCT NCT01294241)
NCT ID: NCT01294241
Last Updated: 2018-01-23
Results Overview
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.
COMPLETED
PHASE2
10 participants
14 days for 'recent wounds', 28 days for 'chronic wounds'
2018-01-23
Participant Flow
Participants were enrolled from 03 Nov 2010 to 14 Jun 2011 at 1 center (University Medical Center Freiburg) in 1 country (Germany).
12 wounds in 10 participants (2 cycles of treatment in 2 participants) were treated with study medication. The reepithelialization was compared intra-individually in either 2 halves of an Epidermolysis bullosa (EB) wound ≥10 cm2 and ≤200 cm2 in size or in 2 EB wounds ≥5 cm2 in size, i.e. the total number of participants was 10 in the overall study.
Unit of analysis: Wounds
Participant milestones
| Measure |
All Study Participants
One (half of an) EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size 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 (intra-individual comparison).
|
|---|---|
|
Overall Study
STARTED
|
10 12
|
|
Overall Study
COMPLETED
|
10 12
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
Baseline characteristics by cohort
| Measure |
All Study Participants
n=12 Wounds
One (half of an) EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
20 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 14 days for 'recent wounds', 28 days for 'chronic wounds'Population: 12 wounds in 10 participants (intra-individual comparison, 2 cycles of treatment in 2 participants) were evaluated by assessors that were blind to treatment. 'Undecided' wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.
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.
Outcome measures
| Measure |
All Study Participants
n=8 Wounds
Intra-individual comparison of two treatments: One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size 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 standard of care control.
|
Non-adhesive Wound Dressing Only
The other half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with non-adhesive wound Dressing only as control.
|
|---|---|---|
|
Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds'
Faster healing of wound treated with Oleogel-S10
|
8 Wounds
|
—
|
|
Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in 'Recent Wounds' or Day 28 in 'Chronic Wounds'
Faster healing of wound treated with dressing
|
0 Wounds
|
—
|
SECONDARY outcome
Timeframe: Day 7±1Population: As 2 participants received 2 cycles of treatment each, 12 wounds were treated with study medication.
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.
Outcome measures
| Measure |
All Study Participants
n=12 Wounds/wound halves
Intra-individual comparison of two treatments: One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size 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 standard of care control.
|
Non-adhesive Wound Dressing Only
n=12 Wounds/wound halves
The other half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with non-adhesive wound Dressing only as control.
|
|---|---|---|
|
Percentage of Wound Epithelialization at Day 7±1
|
69.7 Percentage of wound epithelialization
Interval 17.3 to 90.4
|
57.4 Percentage of wound epithelialization
Interval 10.0 to 81.3
|
SECONDARY outcome
Timeframe: Day 14±1Population: As 2 participants received 2 cycles of treatment each, 12 wounds were treated with study medication.
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.
Outcome measures
| Measure |
All Study Participants
n=12 Wounds/wound halves
Intra-individual comparison of two treatments: One half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size 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 standard of care control.
|
Non-adhesive Wound Dressing Only
n=12 Wounds/wound halves
The other half of an EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with non-adhesive wound Dressing only as control.
|
|---|---|---|
|
Percentage of Wound Epithelialization at Day 14±1
|
87.7 Percentage of wound epithelialization
Interval 2.7 to 100.0
|
79.2 Percentage of wound epithelialization
Interval 0.0 to 98.3
|
Adverse Events
Safety Population
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Safety Population
n=10 participants at risk
All participants who received at least 1 dose of Oleogel-S10 were included in the safety population. All adverse events were reported for all study participants. Localized adverse events were not separately reported by intervention.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Wound area increased due to trauma/wound dressing change
|
50.0%
5/10 • Number of events 9 • Adverse events were recorded from start of study treatment (Day 0) to completion of study treatment (Day 14/Day 28), i.e. for a period of up to 2 or 4 weeks.
|
|
Skin and subcutaneous tissue disorders
Wound infection
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from start of study treatment (Day 0) to completion of study treatment (Day 14/Day 28), i.e. for a period of up to 2 or 4 weeks.
|
|
Infections and infestations
Flu-like syndrome
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from start of study treatment (Day 0) to completion of study treatment (Day 14/Day 28), i.e. for a period of up to 2 or 4 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place