Trial · NCT03389308
Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex
NCT03389308, Phase 2, Completed, Castle Creek Pharmaceuticals, LLC; results first posted 2020-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex. Trials, record NCT03389308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03389308
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex
- NCT number
- NCT03389308
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Castle Creek Pharmaceuticals, LLC
- Conditions
- Epidermolysis Bullosa, Epidermolysis Bullosa Simplex
- Interventions
- diacerein 1% ointment
- First posted
- 2018-01-03
- Last updated
- 2020-09-16
- Results first posted
- 2020-09-16
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-emergent Adverse Events | up to 52 weeks | Number and percentage of participants with any treatment-emergent adverse event. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment-emergent Adverse Events | up to 52 weeks | Safety population: All subjects who received at least one application of diacerein 1% ointment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment-emergent Adverse Events | Diacerein 1% Ointment | 40 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Diacerein 1% Ointment | 51 | |
| Overall Study | COMPLETED | Diacerein 1% Ointment | 39 | |
| Overall Study | NOT COMPLETED | Diacerein 1% Ointment | 12 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Diacerein 1% Ointment | 7 | 51 | 10 |
| other | Skin infection | Infections and infestations | Diacerein 1% Ointment | 5 | 51 | 9 |
| other | Ear infection | Infections and infestations | Diacerein 1% Ointment | 3 | 51 | 3 |
| other | Gastroenteritis viral | Infections and infestations | Diacerein 1% Ointment | 3 | 51 | 3 |
| other | Pyrexia | General disorders | Diacerein 1% Ointment | 4 | 51 | 4 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Diacerein 1% Ointment | 4 | 51 | 5 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Diacerein 1% Ointment | 4 | 51 | 6 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diacerein 1% Ointment | 0 | 51 |
| Total, other adverse events | Diacerein 1% Ointment | 21 | 51 |
| Total, serious adverse events | Diacerein 1% Ointment | 0 | 51 |
Source ClinicalTrials.gov
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/NCT03389308
GET https://conductscience.org/api/trials/v1/NCT03389308/registered