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Amryt Pharma EASE Phase III Clinical Trial to study the efficacy and safety of Oleogel-S10 in Epidermolysis Bullosa

Oleogel-S10 is a topical gel that has demonstrated accelerated wound healing in adult patients with partial thickness wounds. Partial thickness wounds are areas of skin where the upper layers have been lost, for example by a burn or during surgical skin grafting. Oleogel-S10 has been authorised for this particular use by the European Union (EU) under the brand name Episalvan®. The active pharmaceutical ingredient in Oleogel-S10 is a refined birch bark extract.

In the EASE clinical trial the efficacy and safety of Oleogel-S10 will be compared to a gel placebo for the treatment of partial thickness wounds in inherited Epidermolysis Bullosa (EB). The placebo is a sunflower oil based gel that does not contain any active substance. The participant will receive either Oleogel-S10 or placebo for a study phase of 90 days. In the follow-up phase for the study all participants will be treated with Oleogel-S10 for a period of 24 months.

The EASE clinical study will be performed in several countries including the UK. Two key UK sites include Great Ormond Street Hospital in London and Birmingham Children’s Hospital NHS Trust. In total about 164 participants are expected to participate. To take part in any type of clinical trial, the first person to speak with is your own doctor. Your doctor can talk to you about the trials they may be taking part in and assess if you may be medically suitable.

More information about the trial can be found here.