At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with junctional EB (JEB), dystrophic EB (DEB), or Kindler EB
- ✓Age ≥21 days
- ✓EB target wound (partial thickness wound) measuring 10-50 cm² and aged ≥21 days but <9 months old
- ✓Able to provide informed consent or have legal representative provide it
- ✕EB simplex subtype (only JEB, DEB, and Kindler EB allowed)
- ✕Target wound ≥9 months old or showing signs of local infection
- ✕Systemic antibiotics for wound infection within 7 days prior to enrollment
- ✕Systemic or topical steroids within 30 days before enrollment (inhaled, ophthalmic, or topical budesonide for esophageal strictures allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Oleogel-S10 and Control gel for Epidermolysis Bullosa. Completed, enrolled 223 participants across 51 sites in 26 countries.
Detailed Summary
This was 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. 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 carried out to investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe for long-term use. Oleogel-S10 was compared to a control gel. The control gel matched Oleogel-S10 in terms of texture and visual appearance to allow for double-blinding. The packaging for Oleogel-S10 gel and the control gel were identical. The participant received either Oleogel-S10 or control gel for a double-blind study phase of 90 days. The probability that the participant received Oleogel-S10 was 50%, which means that they had a 1 in 2 chance of receiving Oleogel-S10. However, in the follow-up phase of the study all participants were treated with Oleogel-S10 for a period of 24 months. This clinical study was performed at 49 study sites in 26 countries (Argentina, Australia, Austria, Brazil, Chile, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong \[China\], Hungary, Ireland, Israel, Italy, Romania, Russia, Serbia, Singapore, Spain, Switzerland, Ukraine, United Kingdom, and the United States); 223 participants participated in total.
Study Details
Timeline
Interventions
10% birch bark extract in 90% sunflower oil
Sunflower oil, Cera flava/yellow wax, and Carnauba wax (matched Oleogel-S10 in terms of texture and visual appearance)