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NCT03472287 · ClinicalTrials.gov registry record · Phase 1

To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)

A Phase 1 study of Dystrophic Epidermolysis Bullosa and Junctional Epidermolysis Bullosa, sponsored by Castle Creek Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
11
Enrollment target
3
Study locations

NCT03472287 is a Phase 1 study of Dystrophic Epidermolysis Bullosa and Junctional Epidermolysis Bullosa that has completed, run by Castle Creek Pharmaceuticals. The registered enrollment target is 11 participants, below the 19-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (42% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT03472287, a Phase 1 study of Dystrophic Epidermolysis Bullosa and Junctional Epidermolysis Bullosa, has completed, sponsored by Castle Creek Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
11 participants
Enrollment target
3
Study locations

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

Dystrophic Epidermolysis Bullosa Junctional Epidermolysis Bullosa Epidermolysis Bullosa Simplex Epidermolysis Bullosa (EB)

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

FieldValue
Enrollment Target 11 participants
Start Date 2018-05-18
Est. Completion 2019-02-14
Phase Phase 1

Sponsor

Castle Creek Pharmaceuticals

7 total trials

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What the Registry Record Tells You About NCT03472287

The ClinicalTrials.gov registry entry for NCT03472287 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 19-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (42% lower). The listed sponsor is Castle Creek Pharmaceuticals, which has 7 total studies on file at ClinicalTrials.gov.

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.

NCT03472287 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Illinois, North Carolina.

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).

What interventions are being tested in trial NCT03472287?

The interventions under investigation include: Diacerein 1% Ointment (DRUG).

Who is sponsoring clinical trial NCT03472287?

This trial is sponsored by Castle Creek Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.