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

Pivotal Trial

Summary

This trial tested Oleogel-S10, a gel made from birch bark extract, on patients with a rare skin condition called Epidermolysis Bullosa (EB). EB causes fragile skin that blisters easily and forms painful wounds. The gel aims to help these wounds heal faster. The study initially compared Oleogel-S10 to another gel and then treated all participants with Oleogel-S10 for an extended period. Oleogel-S10, containing a betulin-rich triterpene extract from birch bark, has shown promise in accelerating wound healing in previous studies, including those involving patients with dystrophic epidermolysis bullosa.

Eligible Conditions

Epidermolysis Bullosa

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90±7 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Patients With First Complete Closure of the EB Target Wound Within 45 Days of Treatment

Secondary study objectives

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

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