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NCT03472547 · ClinicalTrials.gov registry record · Phase 1
A Study of Sensitizing Potential of Diacerein 1% Ointment in Healthy Subjects
A Phase 1 study of Healthy, sponsored by Castle Creek Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 234
- Enrollment target
- 1
- Study location
NCT03472547: Completed Phase 1 study of Healthy, sponsored by Castle Creek Pharmaceuticals.
NCT03472547 is a Phase 1 study of Healthy that has completed, run by Castle Creek Pharmaceuticals. The registered enrollment target is 234 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03472547, a Phase 1 study of Healthy, has completed, sponsored by Castle Creek Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 234 participants
- Enrollment target
- 1
- Study location
Study Summary
Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the sensitization potential of diacerein 1% ointment under occlusive conditions on normal skin of healthy volunteer subjects.
Primary Outcome
The determination of dermal sensitization potential was based on the recurrence of a cutaneous response at re-challenge that was equivalent or more severe than the cumulative irritation score observed during the challenge period. Cumulative irritation score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome.
Conditions Studied
Interventions
- DRUG diacerein 1% ointment
Study Locations (1)
New Jersey
- TKL Research - Fair Lawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2018-01-15 |
| Est. Completion | 2018-03-03 |
| Phase | Phase 1 |
What the finished NCT03472547 record still lists
NCT03472547 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which diacerein 1% ointment is the first listed.
NCT03472547 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT03472547 about?
NCT03472547 is a clinical study titled "A Study of Sensitizing Potential of Diacerein 1% Ointment in Healthy Subjects". Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the sensitization potential of diacerein 1% ointment under occlusive conditions on normal skin of healthy volunteer subjects.
What is the current status of trial NCT03472547?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 234 participants. The study started on 2018-01-15. Estimated completion is 2018-03-03.
What conditions does trial NCT03472547 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03472547?
The interventions under investigation include: diacerein 1% ointment (DRUG).
Who is sponsoring clinical trial NCT03472547?
This trial is sponsored by Castle Creek Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03472547 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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.
Where NCT03472547's enrollment target sits among peer trials
234 106th of 1090 higher than 984 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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