Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (EASE)
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|ClinicalTrials.gov Identifier: NCT03068780|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : November 12, 2020
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 250 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)|
|Actual Enrollment :||223 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|
|Actual Primary Completion Date :||June 11, 2020|
|Estimated Study Completion Date :||July 2022|
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) in patients with inherited EB (subtypes JEB, DEB, or Kindler syndrome) within 45±7 days of treatment with Oleogel S10 compared to vehicle based on clinical assessment by the investigator (the wound will be rated as "closed" at first appearance of complete reepithelialisation without drainage)
- Time to first complete closure of the EB target wound as evidenced by clinical assessment until EDBP (D90±7) [ Time Frame: 90±7 days ]
- Proportion of patients with first complete closure of the EB target wound at D90±7 based on clinical assessment by the investigator until Day 90±7. [ Time Frame: 90±7 days ]
- The incidence of wound infection between baseline (DBP D0) and D90±7 as evidenced by AEs and/or use of topical and/or systemic antibiotics (related to wound infection) [ Time Frame: 90±7 days ]
- The maximum severity of wound infection between baseline (DBP D0) and D90±7 as evidenced by AEs and/or use of topical and/or systemic antibiotics (related to wound infection) [ Time Frame: 90±7 days ]
- 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±7 [ Time Frame: 90±7 days ]
- Change from baseline (DBP D0) in itching using the 'Itch Man Scale' in patients ≥ 4 years and up to 13 years of age and the 'Leuven Itch Scale' in patients ≥ 14 years of age before wound dressing changes at D90±7 [ Time Frame: 90±7 days ]
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
|Principal Investigator:||Johannes S Kern, MD PhD||Melbourne Health|