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A Double-blind, Randomized, Intra-subject Placebo-controlled, Multicenter, Multiple Dose Study, Evaluating Safety, Proof of Mechanism, Preliminary Efficacy and Systemic Exposure in Subjects With Confirmed DDEB or RDEB Diagnosis With One or More Pathogenic Mutations in Exon 73 in the COL7A1 Gene

NCT03605069 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-08-25

No results posted yet for this study

Summary

A double-blind, randomized, intra-subject placebo-controlled, multicenter, multiple dose study, evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with confirmed DDEB or RDEB diagnosis with one or more pathogenic mutations in exon 73 in the COL7A1 gene.

Conditions

  • Epidermolysis Bullosa Dystrophica, Recessive
  • Epidermolysis Bullosa Dystrophica, Dominant

Interventions

DRUG

QR-313

QR-313 will be applied topically once daily for 8 weeks of treatment.

DRUG

Placebo

Placebo will be applied topically once daily for 8 weeks of treatment.

Sponsors & Collaborators

  • Phoenicis Therapeutics

    lead INDUSTRY

Principal Investigators

  • Clinical Operations · Phoenicis Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2018-12-17
Completion
2018-12-17
FDA Drug
Yes

Countries

  • United States
  • France
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03605069 on ClinicalTrials.gov