Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Dystrophic Epidermolysis Bullosa and Junctional Epidermolysis Bullosa, sponsored by Castle Creek Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What the finished NCT03472287 record still lists
NCT03472287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 19-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (42% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Dystrophic Epidermolysis Bullosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
RECRUITING · Phase 1
-
MSC EVs in Dystrophic Epidermolysis Bullosa
RECRUITING · Phase 1
-
A Phase I/II Study of KB103, a Topical HSV1-COL7, on DEB Patients
COMPLETED · Phase 1
-
A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa
RECRUITING · Phase 3
-
Long-Term Follow-up Protocol
RECRUITING
-
Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03114462 · 11 participants · Phase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
- NCT06039709 · 11 participants · Phase 1
Sonodynamic Therapy in Patients With Recurrent GBM
- NCT06425380 · 11 participants · NA
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- NCT06472661 · 11 participants · Early Phase 1
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI