Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (EASE)
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|ClinicalTrials.gov Identifier: NCT03068780|
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : November 30, 2018
This is a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited Epidermolysis Bullosa (EB).
EB is a rare group of genetic skin fragility disorders characterised by blistering of the skin in response to minor injury. In most cases, onset of EB is at birth or shortly after. All participants affected by any type of EB share the main characteristic of repeatedly developing painful wounds that take days to months to heal. Current treatment of EB is primarily preventative and supportive including protection from mechanical forces by avoiding rubbing, early treatment of wounds to prevent infections, and protection of the wound with adequate non-adhesive dressings to enable healing.
Oleogel-S10 was authorised in 2016 in the European Union for treatment of partial thickness wounds in adults under the brand name Episalvan®. The active pharmaceutical ingredient in Oleogel-S10 is a refined birch bark extract, quantified to 72 to 88% betulin.
This clinical study of Oleogel-S10 in patients with inherited EB has been initiated to investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe in the long term use.
Oleogel-S10 will be compared to a vehicle gel placebo. The placebo is an identical looking sunflower oil gel that does not contain any active substance. The participant will receive either Oleogel-S10 or vehicle gel for a double-blind study phase of 90 days. The probability that the participant will receive Oleogel-S10 is 50%, which means that they have a 1 in 2 chance of receiving Oleogel-S10. However, in the follow-up phase of the study all participants will be treated with Oleogel S10 for a period of 24 months.
This clinical study will be performed in several countries; in total, about 164 participants are expected to participate.
|Condition or disease||Intervention/treatment||Phase|
|Epidermolysis Bullosa||Drug: Oleogel-S10 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Double Blind, Randomised, Vehicle Controlled, Phase III, Efficacy and Safety Study With 24-month Open-label Follow up of Oleogel-S10 in Patients With Inherited Epidermolysis Bullosa|
|Actual Study Start Date :||March 29, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||September 2020|
10% birch bark extract in 90% sunflower oil
Other Name: Episalvan
|Placebo Comparator: Placebo||
Sunflower oil gel
Other Name: Vehicle gel
- Proportion of patients with first complete closure of the EB target wound within 45 days of treatment [ Time Frame: 45±7 days ]Proportion of patients with first complete closure of the EB target wound (defined as EB partial thickness wound of 10 cm² to 50 cm² in size aged ≥21 days and <9 months) within 45±7 days of treatment with Oleogel-S10 compared to placebo based on clinical assessment by the investigator (the wound will be rated as "closed" at first appearance of complete reepithelialisation without drainage confirmed by a second observation within the following week)
- Time to first complete closure of the EB target wound as evidenced by clinical assessment until Day 90±7. [ Time Frame: 90±7 days ]Time to first complete closure of the EB target wound (defined as EB partial thickness wound of 10 cm² to 50 cm² in size aged ≥21 days) within 90±7 days of treatment with Oleogel-S10 compared to placebo based on clinical assessment by the investigator (the wound will be rated as "closed" at first appearance of complete reepithelialisation without drainage confirmed by a second observation within the following week)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068780
|Contact: Head of Clinical Developmentemail@example.com|
|Contact: Medical Monitor, MDfirstname.lastname@example.org|
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|Principal Investigator:||Johannes S Kern, MD PhD||Melbourne Health|