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NCT03472534 · ClinicalTrials.gov registry record · Phase 1

A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment

A Phase 1 study, sponsored by Castle Creek Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
46
Enrollment target

NCT03472534: Completed Phase 1 study, sponsored by Castle Creek Pharmaceuticals.

NCT03472534 is a Phase 1 study that has completed, run by Castle Creek Pharmaceuticals. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03472534, a Phase 1 study, has completed, sponsored by Castle Creek Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
46 participants
Enrollment target

Study Summary

Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the irritation potential of diacerein1% ointment on normal skin of healthy volunteers, using a cumulative irritancy patch test (CIPT) procedure.

Primary Outcome

Evaluation of the sum of all subjects' cumulative irritation scores for 21 days at each patch site. 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.

Interventions

  • DRUG diacerein 1% ointment

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2018-01-09
Est. Completion 2018-01-30
Phase Phase 1
Castle Creek Pharmaceuticals

7 total trials

What the finished NCT03472534 record still lists

NCT03472534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 1 intervention - of which diacerein 1% ointment is the first listed.

NCT03472534 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03472534 about?

NCT03472534 is a clinical study titled "A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment". Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the irritation potential of diacerein1% ointment on normal skin of healthy volunteers, using a cumulative irritancy patch test (CIPT) procedure.

What is the current status of trial NCT03472534?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2018-01-09. Estimated completion is 2018-01-30.

What interventions are being tested in trial NCT03472534?

The interventions under investigation include: diacerein 1% ointment (DRUG).

Who is sponsoring clinical trial NCT03472534?

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

How this trial's enrollment target compares

Where NCT03472534's enrollment target sits among peer trials

46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03472534, the US trial registry maintained by the National Library of Medicine. NCT03472534 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.