FCX-007 for Epidermolysis Bullosa

Phase 1 & 2

Waitlist Available

Research Sponsored by Castle Creek Biosciences, LLC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through week 52

Awards & highlights

Study Summary

This trial is testing a drug to see if it's safe for people with a genetic skin condition that makes them heal slowly.

Eligible Conditions

Epidermolysis Bullosa Dystrophica

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Secondary outcome measures

Complete Wound Closure

Trial Design

1Treatment groups

Experimental Treatment

Group I: FCX-007Experimental Treatment1 Intervention

In Phase I, a target of three adult subjects will be enrolled into Group A and a target of three adult subjects will be enrolled into Group B. In Phase II the study will target enrolling subjects (aged seven (7 years or older) to each arm, but will allow a disproportionate distribution of subjects between Group A and Group B to equal approximately 6 total subjects. All subjects will receive FCX-007 into one or more paired target wounds as well as to intact skin at least one time during the study with a possible second administration pending laboratory results. One wound in each target wound pair will be used as control for efficacy and safety evaluations.

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Who is running the clinical trial?

Castle Creek Biosciences, LLC.Lead Sponsor

10 Previous Clinical Trials

639 Total Patients Enrolled

1 Trials studying Epidermolysis Bullosa

6 Patients Enrolled for Epidermolysis Bullosa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available in this clinical examination?

"The most recent update on clinicaltrials.gov confirms that this research is not currently recruiting participants, despite being first published in July 2016. There are still 28 other trials actively enrolling patients at the moment."

Answered by AI

What is the desired outcome of this investigation?

"The primary endpoint of this medical study, assessed over a period of one year post-treatment, is the incidence of adverse events. Other objectives include measuring changes in wound size based on investigator assessments and levels of collagen VII via immunofluorescence imaging; additionally, investigators will monitor for complete wound closure (greater than 90%) at all follow-up visits."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

2016. "A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02810951.