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Birch Bark Extract

Oleogel-S10 for Epidermolysis Bullosa (EASE Trial)

Phase 3
Waitlist Available
Led By Johannes S Kern, MD PhD
Research Sponsored by Amryt Research Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90±7 days
Awards & highlights

EASE Trial Summary

This trial is studying a gel made from birch bark extract to see if it is effective and safe for treating wounds in people with a rare genetic skin condition called inherited epidermolysis bullosa (EB).

EASE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90±7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90±7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Patients With First Complete Closure of the EB Target Wound Within 45 Days of Treatment
Secondary outcome measures
Change From Baseline (DBP D0) in Itching Using the 'Itch Man Scale' in Patients ≥ 4 Years and up to 13 Years of Age Before Wound Dressing Changes at D90 or EDBP
Change From Baseline (DBP D0) in Itching Using the 'Leuven Itch Scale' in Patients ≥ 14 Years of Age Before Wound Dressing Changes at D90 or End of Double Blind Phase (EDBP)
Change From Baseline (DBP D0) in Total Body Wound Burden as Evidenced by Clinical Assessment Using Section I (Assessment of the Skin Except for the Anogenital Region) of the 'EB Disease Activity and Scarring Index' (EBDASI), at D90 or EDBP
+4 more

Side effects data

From 2022 Phase 3 trial • 223 Patients • NCT03068780
54%
Wound complication
13%
Pyrexia
9%
Wound infection
7%
Cough
6%
Nasopharyngitis
5%
Pruritus
5%
Influenza
4%
Anaemia
4%
Wound infection bacterial
3%
Wound infection staphylococcal
2%
Hypoalbuminaemia
2%
Sepsis
2%
Diarrhoea
1%
Erysipelas
1%
Hepatic function abnormal
1%
Oesophageal stenosis
1%
Dysphagia
1%
Femur fracture
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Gel (DBP)
Oleogel-S10 (DBP)
Former Oleogel-S10 (OLP)
Former Control Gel (OLP)

EASE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oleogel-S10Experimental Treatment1 Intervention
Group II: Control GelPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oleogel-S10
2010
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Amryt Research LimitedLead Sponsor
Johannes S Kern, MD PhDPrincipal InvestigatorMelbourne Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa
2017. "Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03068780.
~28 spots leftby Apr 2025
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