Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa
Status:
Active, not recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
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.