Wound closure in epidermolysis bullosa: data from the vehicle arm of the phase 3 ESSENCE Study.

ABSTRACT:

Background

Chronic wounds are a fundamental issue for patients with epidermolysis bullosa (EB). Herein, we assess the natural history of wound closure in patients with EB who were randomly assigned to the vehicle-control arm of the multicenter, randomized, double-blind, phase 3 ESSENCE (NCT02384460) trial.

Methods

ESSENCE was designed to assess the efficacy and safety of a topical cream formulation of 6% allantoin (SD-101 6%) vs vehicle (SD-101 0%) in patients ≥1 month old who had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10-50 cm² present for ≥21 days. Time to complete target wound closure and the proportion of patients with target wound closure over time were analyzed overall and by parameters including pati

SUBMITTER: Murrell DF 

PROVIDER: S-EPMC7374851 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature