Trial · NCT06073132
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)
NCT06073132, Phase 2, Phase 3, Active not recruiting, TWi Biotechnology, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT06073132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06073132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT06073132
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 80 participants, estimated
- Lead sponsor
- TWi Biotechnology, Inc.
- Conditions
- Generalized Epidermolysis Bullosa Simplex
- Interventions
- AC-203, Vehicle
- First posted
- 2023-10-10
- Last updated
- 2026-07-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT) | The static IGA is the investigator's visual clinical assessment of the average overall intensity of lesions in the designated Treatment Area at a particular time point. EBS-IGA is a 5-point scale is a 5-point scale (clear=0; almost clear=1; mild=2; moderate=3; severe=4) |
| Secondary | Change in % BSA of EBS lesions in the Treatment Area | from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT) | The Body Surface Area (BSA) of the Assessment Area will be collected for all lesions included within the Treatment Area using the palmar method |
| Secondary | Change in pain intensity score | Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT) | Wong-Baker FACES® Pain Rating Scale will be used for patients 3 years and older. |
| Secondary | Change in pruritus intensity score | from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT) | ItchyQuant will be used for patients aged 6 years and older, including adult patients |
| Secondary | Change in EBDASI score (skin activity) | from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT). | The EBDASI is a valid and reliable EB-specific outcome measurement tool to assess the overall extent of disease activity and damage in patients with various subtypes of EB, including EBS. Section I (skin), the severity of disease, including erosion/blisters/crusting etc., will be measured at 12 different skin sites. |
| Secondary | Change in the QOLEB score | from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT) | The Life Epidermolysis Bullosa (QOLEB) questionnaire is a valid and reliable, EB-specific QOL measurement tool, for the quantification of QOL in patients with various subtypes of EB, including EBS. It consists of 17 questions with four response choices from "not at all" to "constant" |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06073132
GET https://conductscience.org/api/trials/v1/NCT06073132/registered