Topical Diacerein in Psoriasis Vulgaris (DIA)

January 11, 2026 updated by: Alaa Ashraf Muhammad Helal, Cairo University

The Efficacy of Topical Diacerein Cream in Patients With Psoriasis Vulgaris

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Kasr Al-Ainy Psoriasis Unit
        • Contact:
          • Yousra A Azzazi, PhD, Faculty of Medicine
          • Phone Number: +20 109 870 9984
        • Principal Investigator:
          • Yousra A Azzazi, PhD, Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years old of both genders.
  • Patients with mild chronic plaque psoriasis body surface area (BSA < 10%) along with Psoriasis Area and Severity Index (PASI) score of < 10, and/or Dermatology Life Quality Index (DLQI) score of <10.

Exclusion Criteria:

  • Documented hypersensitivity or idiosyncratic reaction to the investigational product or any excipients contained within the cream formulation.
  • Intake of anti-psoriatic systemic therapy within the last 3 months, or topical treatments within the last 2 weeks.
  • Patients with pustular psoriasis.
  • Pregnant and breast-feeding individuals.
  • Patients with psoriatic arthritis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical Diacerein
Participants assigned to this arm will receive topical diacerein cream 1% applied twice daily for a treatment period of two months.
Drug: Diacerein
Topical diacerein cream 1% will be applied to affected skin areas twice daily for a treatment duration of two months.
Other Names:
  • Topical diacerein
Placebo Comparator: Placebo
Participants assigned to this arm will receive a matching placebo topical cream applied twice daily for a treatment period 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.
Other Names:
  • Matching placebo topical formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving PASI 75
Time Frame: Week 8
The proportion of participants who achieve at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75), comparing the topical diacerein group with the placebo group.
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving IGA/Body-IGA Success
Time Frame: Week 8
The proportion of participants achieving Investigator's Global Assessment (IGA) or Body-IGA success, defined as a score of clear or almost clear with at least a 2-grade improvement from baseline
Week 8
Proportion of Participants Achieving PASI 90
Time Frame: Week 8
The percentage of participants achieving at least a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90).
Week 8
Proportion of Participants Achieving DLQI ≤5
Time Frame: Week 8
Percentage of participants with a Dermatology Life Quality Index (DLQI) total score of ≤5.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP 3.2.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision regarding the sharing of individual participant data (IPD) has not yet been finalized. The availability of IPD will be determined at a later date based on ethical approvals, participant consent, data protection requirements, and institutional and sponsor policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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