Efficacy of Topical Metformin in Psoriasis Vulgaris

Efficacy and Safety of Topical Metformin in Psoriasis Vulgaris: A Randomized, Double Blinded, Placebo-controlled Study.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Placebo; Drug: Topical metformin 30% cream

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasmine A Obaid, MSc; Phone Number: 02-01270047877; Email: yasmeenahmed013@gmail.com

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 02
      • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin; patient with mild psoriasis with PASI less than 10% will receive topical metformin 30% cream twice daily	Drug: Topical metformin 30% cream; Metformin 30% loaded cream will be prepared using stearic acid as a lipid phase for group 1.
Placebo Comparator: Placebo; patients with mild psoriasis vulgaris will receive placebo cream twice daily	Drug: Placebo; a plain similar cream (without metformin) will be prepared as a placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment and comparison of tissue levels of interleukin 17 (IL - 17) between the topical metformin and placebo group.	8 weeks after starting treatment
Comparison of percent PASI improvement from baseline between the topical metformin and placebo groups.	8 weeks after starting treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	8 weeks after starting treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Biguanides; Guanidines; Amidines; Metformin
• Other Study ID Numbers: DERM-MET-PSO-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No