NCT07352306

Topical Diacerein in Psoriasis Vulgaris

The Efficacy of Topical Diacerein Cream in Patients With Psoriasis Vulgaris

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of topical diacerein in adults with psoriasis vulgaris. The primary objective of the study is to compare the proportion of participants who achieve a clinically meaningful improvement in disease severity between the topical diacerein group and the placebo group. Participants will: Be assigned to receive topical diacerein 1% or placebo twice daily for a treatment period of 2 months. Attend follow-up visits at Weeks 2, 4, 6, and 8. Undergo an additional evaluation one month after treatment cessation.

Detailed description

This is a phase IV, randomized, placebo-controlled, double-blind clinical study designed to evaluate the efficacy and safety of topical diacerein in adults with psoriasis vulgaris. Participants who meet eligibility criteria will be randomized to receive either topical diacerein or matching placebo. The study treatment will be applied twice daily for two months. Participants will attend follow-up visits at Weeks 2, 4, 6, and 8, during which clinical evaluations, safety assessments, and efficacy measurements will be conducted. The primary efficacy endpoint is the proportion of participants achieving at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week 8. Secondary endpoints may include additional PASI response thresholds, investigator global assessments, patient-reported outcomes, and safety endpoints. Safety will be monitored throughout the study through the collection of adverse events, physical examinations, and other relevant clinical assessments.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	Diacerein	Topical diacerein cream 1% will be applied to affected skin areas twice daily for a treatment duration of two months.
DRUG	Placebo	A matching placebo topical formulation will be applied to affected skin areas twice daily for a treatment duration of two months.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2027-05-01
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: Egypt