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Part A AC-203 for Epidermolysis Bullosa Simplex

Phase 2 & 3

Recruiting

Research Sponsored by TWi Biotechnology, Inc.

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 baseline a (visit 2/day 1) to week 8 (visit 5/eot)

Awards & highlights

Study Summary

This trial will test a new ointment called diacerein 1% on patients with a skin condition called generalized EBS to see if it is effective and safe.

Who is the study for?

This trial is for patients at least 6 months old with severe or intermediate Generalized Epidermolysis Bullosa Simplex (EBS), confirmed by genetic diagnosis. They must have a specific severity of EBS lesions and be willing to follow the study's medication application instructions, report all medication use, and attend all study visits.Check my eligibility

What is being tested?

The trial is testing diacerein 1% ointment versus a placebo (vehicle) to see if it's effective and safe for treating generalized EBS. It includes an initial phase where neither the researchers nor participants know who gets which treatment, followed by an open-label phase where everyone knows.See study design

What are the potential side effects?

While not specified here, side effects may include local skin reactions at the site of ointment application such as redness, itching or burning sensation. Systemic side effects are less common but could potentially occur depending on how much ointment is absorbed through the skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline a (visit 2/day 1) to week 8 (visit 5/eot)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline a (visit 2/day 1) to week 8 (visit 5/eot)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline a (visit 2/day 1) to week 8 (visit 5/eot) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of patients achieving treatment success on the IGA of the Treatment Area, in which treatment success is defined as a score of 0 or 1 with at least a 2-point reduction

Secondary outcome measures

Change in % BSA of EBS lesions in the Treatment Area

Change in EBDASI score (skin activity)

Change in pain intensity score (Numeric Rating Scale for pain)

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B AC-203Experimental Treatment1 Intervention

Open-label extension phase, AC-203 Diacerein 1% ointment, QD

Group II: Part A AC-203Experimental Treatment1 Intervention

Double-blind, AC-203 Diacerein 1% ointment, QD

Group III: Part A Vehicle ointmentPlacebo Group1 Intervention

Double-blind, Vehicle ointment, QD

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AC-203

2018

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

TWi Biotechnology, Inc.Lead Sponsor

9 Previous Clinical Trials

612 Total Patients Enrolled

Frequently Asked Questions

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

Are potential participants currently able to apply for enrollment in this clinical trial?

"Yes, the information available on clinicaltrials.gov indicates that this clinical trial is actively seeking participants. Initially shared on April 1st, 2024 and most recently revised on the same day in 2024, this trial aims to enroll 80 individuals across a dozen designated locations."

Answered by AI

At how many distinct sites is this research study currently being overseen?

"At the moment, enrollment is ongoing at 12 different medical centers. In addition to Chicago, Charleston, and San Antonio, there are a dozen more locations where patients can participate in this study. Opting for the nearest site would help reduce travel burdens once you decide to enroll."

Answered by AI

How large is the overall participant population involved in this research endeavor?

"The study necessitates the enrollment of 80 eligible participants meeting its criteria. The trial will be overseen by TWi Biotechnology, Inc., with activity spanning multiple sites such as Northwestern University - Lurie Children's Hospital in Chicago, Illinois, and Medical University of South carolina in Charleston, South Carolina."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study With Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS)

2024. "An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study With Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06073132.

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