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 ScorePrimary· 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
Group
Value
95% CI
Single Cohort (Healthy Volunteers)
10
Diacerein irradiated max score 1 at 48 hrs
Group
Value
95% CI
Single Cohort (Healthy Volunteers)
3
Diacerein irradiated max score 1 at 72 hrs
Group
Value
95% CI
Single Cohort (Healthy Volunteers)
1
Diacerein non-irradiated max score 1 at 24 hrs
Group
Value
95% CI
Single Cohort (Healthy Volunteers)
0
Diacerein non-irradiated max score 1 at 48 hrs
Group
Value
95% CI
Single Cohort (Healthy Volunteers)
0
Diacerein non-irradiated max score 1 at 72 hrs
Group
Value
95% CI
Single Cohort (Healthy Volunteers)
0
Vehicle irradiated max score 1 at 24 hrs
Group
Value
95% CI
Single Cohort (Healthy Volunteers)
10
Vehicle irradiated max score 1 at 48 hrs
Group
Value
95% 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):
NCT03473184 — A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers
· Phase 1
· completed
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Trials by the same sponsor.
NCT03472287 — To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
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NCT03472547 — A Study of Sensitizing Potential of Diacerein 1% Ointment in Healthy Subjects
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NCT03472534 — A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment
· Phase 1
· completed
NCT03473184 — A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers
· Phase 1
· completed
NCT03389308 — Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Castle Creek Pharmaceuticals, LLC
Last refreshed: 5 February 2020
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.