Trial · NCT03472287
To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
NCT03472287, Phase 1, Completed, Castle Creek Pharmaceuticals, LLC; results first posted 2020-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB). Trials, record NCT03472287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03472287
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
- NCT number
- NCT03472287
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 11 participants, actual
- Lead sponsor
- Castle Creek Pharmaceuticals, LLC
- Conditions
- Epidermolysis Bullosa (EB), Epidermolysis Bullosa Simplex, Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
- Interventions
- Diacerein 1% Ointment
- First posted
- 2018-03-21
- Last updated
- 2020-02-10
- Results first posted
- 2020-02-10
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Detectable Plasma Concentrations of Diacerein and Rhein | Days 1-10, at select time points per protocol | Bioanalytical analyses were performed to determine concentrations levels of diacerein and rhein in plasma using validated bioanalytical methods. For Cohort 1, blood samples were taken at pre-dose and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. For Cohort 2, blood samples were taken at pre-dose and 1, 2, 4, 6, and 8 hours post-dose. Trough PK samples were collected on any 2 available days from Days 3 through 9 for Cohort 1 only. Summary statistics for each scheduled time were only reported if at least 50% of subjects had quantifiable concentrations. |
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 | Detectable Plasma Concentrations of Diacerein and Rhein | Days 1-10, at select time points per protocol | Cohort 1: 4 adolescent/adult subjects with EBS, 4 adolescent/adult subjects with DEB; Cohort 2: 3 child subjects with EBS | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Detectable Plasma Concentrations of Diacerein and Rhein | Cohort 1 (Adolescents, Adults) | Rhein Below the limit of quantification:EBS | 3 | Participants | |
| Detectable Plasma Concentrations of Diacerein and Rhein | Cohort 2 (Children) | Rhein Below the limit of quantification:EBS | 2 | Participants | |
| Detectable Plasma Concentrations of Diacerein and Rhein | Cohort 1 (Adolescents, Adults) | Rhein Below the limit of quantification:DEB | 0 | Participants | |
| Detectable Plasma Concentrations of Diacerein and Rhein | Cohort 2 (Children) | Rhein Below the limit of quantification:DEB | 0 | Participants | |
| Detectable Plasma Concentrations of Diacerein and Rhein | Cohort 1 (Adolescents, Adults) | Rhein Above Lower limit of quantification:EBS | 1 | Participants | |
| Detectable Plasma Concentrations of Diacerein and Rhein | Cohort 2 (Children) | Rhein Above Lower limit of quantification:EBS | 1 | Participants | |
| Detectable Plasma Concentrations of Diacerein and Rhein | Cohort 1 (Adolescents, Adults) | Rhein Above Lower limit of quantification:DEB | 4 | Participants | |
| Detectable Plasma Concentrations of Diacerein and Rhein | Cohort 2 (Children) | Rhein Above Lower limit of quantification:DEB | 0 | Participants | |
| Detectable Plasma Concentrations of Diacerein and Rhein | Cohort 1 (Adolescents, Adults) | Diacerein Below the limit of quantification:EBS | 4 | Participants | |
| Detectable Plasma Concentrations of Diacerein and Rhein | Cohort 2 (Children) | Diacerein Below the limit of quantification:EBS | 3 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (Adolescents, Adults) | 8 | |
| Overall Study | STARTED | Cohort 2 (Children) | 3 | |
| Overall Study | COMPLETED | Cohort 1 (Adolescents, Adults) | 8 | |
| Overall Study | COMPLETED | Cohort 2 (Children) | 3 | |
| Overall Study | NOT COMPLETED | Cohort 1 (Adolescents, Adults) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 (Children) | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Pyrexia | General disorders | Cohort 1 (Adolescents, Adults) | 1 | 8 | 1 |
| other | Pyrexia | General disorders | Cohort 2 (Children) | 0 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (Adolescents, Adults) | 0 | 8 |
| Total, all-cause mortality | Cohort 2 (Children) | 0 | 3 |
| Total, other adverse events | Cohort 1 (Adolescents, Adults) | 1 | 8 |
| Total, other adverse events | Cohort 2 (Children) | 0 | 3 |
| Total, serious adverse events | Cohort 1 (Adolescents, Adults) | 0 | 8 |
| Total, serious adverse events | Cohort 2 (Children) | 0 | 3 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 (Adolescents, Adults) vs Cohort 2 (Children): deaths from any cause | Trial comparisons |
| Cohort 1 (Adolescents, Adults) vs Cohort 2 (Children): serious adverse events | Trial comparisons |
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/NCT03472287
GET https://conductscience.org/api/trials/v1/NCT03472287/registered