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To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
NCT03472287 · View on ClinicalTrials.gov ↗
Study Summary
A pharmacokinetic (PK) study in 16-20 EB subjects to be allocated to two cohorts. Cohort 1 to include 8-10 subjects (ages 12 yrs and older); Cohort 2 to include 8-10 subjects (ages 6 months-11 yrs, inclusive). Cohort 2 only included subjects 4 yrs and older. Serial PK blood sampling collected on Days 1 and 10. Analyses were performed to determine the concentrations of diacerein and rhein.
Conditions Studied
Interventions
- DRUG Diacerein 1% Ointment
Study Locations (3)
California
- Stanford School of Medicine — Palo Alto
Illinois
- Northwestern University Medical Center — Chicago
North Carolina
- UNC Dermatology — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-05-18 |
| Est. Completion | 2019-02-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03472287
The ClinicalTrials.gov registry entry for NCT03472287 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Castle Creek Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Dystrophic Epidermolysis Bullosa appearing as the primary indexed condition, and to 1 intervention — of which Diacerein 1% Ointment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03472287 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Illinois, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03472287 about?
NCT03472287 is a clinical study titled "To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)". A pharmacokinetic (PK) study in 16-20 EB subjects to be allocated to two cohorts. Cohort 1 to include 8-10 subjects (ages 12 yrs and older); Cohort 2 to include 8-10 subjects (ages 6 months-11 yrs, inclusive). Cohort 2 only included subjects 4 yrs and older. Serial PK blood sampling collected on Day...
What is the current status of trial NCT03472287?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-05-18. Estimated completion is 2019-02-14.
What conditions does trial NCT03472287 study?
This clinical trial studies the following conditions: Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Epidermolysis Bullosa Simplex, Epidermolysis Bullosa (EB). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03472287?
The interventions under investigation include: Diacerein 1% Ointment (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03472287?
This trial is sponsored by Castle Creek Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03472287 being conducted?
This trial has 3 study locations across California, Illinois, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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