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Topical Diacerein in Psoriasis Vulgaris

ConditionPsoriasis Vulgaris
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diacerein

    Drug

    Topical diacerein cream 1% will be applied to affected skin areas twice daily for a treatment duration of two months.

  • Placebo

    Drug

    A matching placebo topical formulation will be applied to affected skin areas twice daily for a treatment duration of two months.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Topical DiacereinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants Achieving PASI 75

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.

Time frame
Week 8

Secondary outcomes

1

Proportion of Participants Achieving IGA/Body-IGA Success

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

Time frame
Week 8
2

Proportion of Participants Achieving PASI 90

The percentage of participants achieving at least a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90).

Time frame
Week 8
3

Proportion of Participants Achieving DLQI ≤5

Percentage of participants with a Dermatology Life Quality Index (DLQI) total score of ≤5.

Time frame
Week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: