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Clinical Trials/EUCTR2016-002066-32-IE
EUCTR2016-002066-32-IE
Active, not recruiting
Phase 1

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 - EASE study

Amryt Research Limited0 sites250 target enrollmentMarch 7, 2017
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ConditionsInherited Epidermolysis BullosaMedDRA version: 20.0Level: PTClassification code 10014989Term: Epidermolysis bullosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsEpisalvan gel

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Inherited Epidermolysis Bullosa
Sponsor
Amryt Research Limited
Enrollment
250
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 7, 2017
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Amryt Research Limited

Eligibility Criteria

Inclusion Criteria

  • •A patient will be eligible for study participation only if all of the following
  • •criteria apply:
  • •1\. Male and female patients aged \=4 years with the following subtypes
  • •of inherited EB: JEB, DEB, and Kindler syndrome \[Note: Children \=21
  • •days old and \<4 years may be included only after confirmation by the
  • •Independent Data Monitoring Committee (IDMC) upon review of the
  • •safety and bioanalytical data at the interim safety review stage]
  • •2\. Patients with an EB target wound (i.e., EB partial thickness wound of
  • •10 cm2 to 50 cm2 in size aged \=21 days and \<9 months) outside of the anogenital region
  • •3\. Patient and/or his/her legal representative has/have been informed, has/have read and understood the patient information/informed

Exclusion Criteria

  • •A patient will not be eligible to participate in this study if any of the
  • •following criteria apply:
  • •1\. Patient has EB subtype EBS
  • •2\. EB target wound that is \> 9 months old or has clinical signs of local
  • •3\. Use of systemic antibiotics for wound\-related infections within 7 days
  • •prior to enrolment
  • •4\. Administration of systemic or topical steroids (except for inhaled,
  • •ophthalmic or topical applications, such as budesonide suspension for
  • •oesophageal strictures \[e.g., Pulmicort Respules® 0\.25 mg/2 mL or 0\.5
  • •mg/2 mL]) within 30 days before enrolment

Outcomes

Primary Outcomes

Not specified

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