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NCT03473197

A 6-Week Study to Evaluate the Photoallergic Potential of Diacerein 1% Ointment in Healthy Volunteers

Completed Phase 1 Results posted Last updated 5 February 2020
What this trial tests

Phase 1 trial testing Diacerein 1% ointment in Healthy in 61 participants. Completed in 9 March 2018.

Timeline
8 January 2018
Primary endpoint
9 March 2018
9 March 2018

Quick facts

Lead sponsorCastle Creek Pharmaceuticals, LLC
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment61
Start date8 January 2018
Primary completion9 March 2018
Estimated completion9 March 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Castle Creek Pharmaceuticals, LLC — full company profile →

Who can join

18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score Primary · Skin sites evaluated 24, 48, and 72 hours after patch removal and irradiation challenge

The determination of photosensitization reactions was summarized by frequency counts of the total dermal irritation score during the Challenge Phase. Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score=0, maximum score=5; higher score=worse outcome

Diacerein irradiated max score 1 at 24 hrs
GroupValue95% CI
Single Cohort (Healthy Volunteers)10
Diacerein irradiated max score 1 at 48 hrs
GroupValue95% CI
Single Cohort (Healthy Volunteers)3
Diacerein irradiated max score 1 at 72 hrs
GroupValue95% CI
Single Cohort (Healthy Volunteers)1
Diacerein non-irradiated max score 1 at 24 hrs
GroupValue95% CI
Single Cohort (Healthy Volunteers)0
Diacerein non-irradiated max score 1 at 48 hrs
GroupValue95% CI
Single Cohort (Healthy Volunteers)0
Diacerein non-irradiated max score 1 at 72 hrs
GroupValue95% CI
Single Cohort (Healthy Volunteers)0
Vehicle irradiated max score 1 at 24 hrs
GroupValue95% CI
Single Cohort (Healthy Volunteers)10
Vehicle irradiated max score 1 at 48 hrs
GroupValue95% CI
Single Cohort (Healthy Volunteers)3

Sponsor's own description

A study in healthy male and female adult volunteers to determine the potential of diacerein 1% ointment to induce a photoallergic skin reaction using a controlled photopatch testing procedure.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Advances in Drug Delivery Science for Diacerein: Strategies to Enhance Solubility, Bioavailability, and Pharmacokinetic Performance.
    Naseri M, Ghobakhlou S, Heidarizade N, Akbari ME, et al · · 2025 · PMID 41471053 · DOI 10.3390/pharmaceutics17121539

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Other trials of Diacerein 1% ointment

Trials testing the same drug.

Other recruiting trials for Healthy

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Other Castle Creek Pharmaceuticals, LLC trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03473197.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing