Efficacy of Topical Metformin in Psoriasis Vulgaris
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical metformin 30% cream, Placebo.
- Who it may be relevant to
- Registry conditions: Psoriasis Vulgaris. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Topical Metformin in Psoriasis Vulgaris: A Randomized, Double Blinded, Placebo-controlled Study.
Overview
The goal of this clinical trial is to learn if topical metformin works to treat mild psoriasis vulgaris. It will also learn about the safety of topical metformin. The main questions it aims to answer are: Does topical metformin improve psoriatic plaques in early psoriasis? What medical problems do participants have when use topical metformin? Researchers will compare topical metformin to a placebo (a look-alike substance that contains no drug) to see if topical metformin works to treat psoriasis vulgaris. Participants will: put topical metformin or placebo twice daily for 2 months. Visit the clinic once every months for follow up. Keep a diary of their symptoms and any side effects. Skin biopsy will be taken from psoriatic plaque before starting treatment and another one will be taken after 2 months of starting treatment to assess the level of IL-17.
Interventions
- Drug Topical metformin 30% cream
Metformin 30% loaded cream will be prepared using stearic acid as a lipid phase for group 1. - Drug Placebo
a plain similar cream (without metformin) will be prepared as a placebo.
Primary outcome measures
- Assessment and comparison of tissue levels of interleukin 17 (IL - 17) between the topical metformin and placebo group. [Time frame: 8 weeks after starting treatment]
- Comparison of percent PASI improvement from baseline between the topical metformin and placebo groups. [Time frame: 8 weeks after starting treatment]
Secondary outcome measures (1)
- Comparison of percentage of patients who achieved ≥4-point improvement from baseline worst itch numeric rating score (WI- NRS) between the topical metformin and placebo groups. [Time frame: 8 weeks after starting treatment]
Eligibility criteria
Inclusion criteria
- Patients ≥ 18 years old
- Patients of both genders
- Patients with mild chronic plaque psoriasis ((PASI) < 10, and body surface area (BSA) < 10% and/or Dermatology Life Quality Index (DLQI) <10).
Exclusion criteria
- Intake of anti-psoriatic systemic therapy within the last 3 months apart from retinoids, or topical treatments within the last 2 weeks.
- Intake of systemic metformin.
- Intake of other systemic drugs that exacerbate psoriasis as anti-malarial drugs, Angiotensin- converting-enzyme inhibitors (ACEI), Ca channel blockers (CCBs) and beta blockers or intake of non-steroidal anti- inflammatory drugs (NSAID) within the last 2 weeks.
- Patients with psoriatic arthritis.
- Patients with pustular psoriasis.
- Pregnant and Lactating females.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07516821 · DERM-MET-PSO-2026-01