Topical Diacerein in Psoriasis Vulgaris (DIA)

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Psoriasis Vulgaris

Treatments: Drug: Diacerein; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07352306

CP 3.2.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Topical Diacerein

Experimental group

Description:

Participants assigned to this arm will receive topical diacerein cream 1% applied twice daily for a treatment period of two months.

Treatment:

Drug: Diacerein

Placebo

Placebo Comparator group

Description:

Participants assigned to this arm will receive a matching placebo topical cream applied twice daily for a treatment period of two months.

Treatment:

Drug: Placebo