Psoriasis Vulgaris
Conditions
Keywords
Diacerein, Psoriasis vulgaris, Topical, Interleukin-1β inhibitor, Randomized controlled trial
Brief 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.
Interventions
DRUGDiacerein
Topical diacerein cream 1% will be applied to affected skin areas twice daily for a treatment duration of two months.
DRUGPlacebo
A matching placebo topical formulation will be applied to affected skin areas twice daily for a treatment duration of two months.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will be randomly assigned to study groups using a computer-generated allocation sequence. Allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed envelopes prepared by an independent individual and opened only after eligibility confirmation and informed consent. The investigational product and placebo will be identical in appearance and texture and prepared by qualified study personnel. Both participants and treating clinicians will remain blinded to treatment assignment for the duration of the study.
Intervention model description
This study is designed as a prospective, randomized, double-blind, parallel-arm, placebo-controlled clinical trial. Participants will be randomly assigned in a 1:1 ratio to receive either topical diacerein cream or a matching placebo cream. Participants will remain in their assigned treatment arm for the duration of the study, with outcomes assessed according to the prespecified schedule. No crossover between treatment arms is planned.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving PASI 75 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving IGA/Body-IGA Success | 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 |
| Proportion of Participants Achieving PASI 90 | Week 8 | The percentage of participants achieving at least a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90). |
| Proportion of Participants Achieving DLQI ≤5 | Week 8 | Percentage of participants with a Dermatology Life Quality Index (DLQI) total score of ≤5. |
Countries
Egypt
Contacts
CONTACTAlaa A Helal, BSc in Pharmacy
Outcome results
None listed