Efficacy of Topical Metformin in Psoriasis Vulgaris

NCT07516821 | Not Yet Recruiting DMC

• 1 other identifier: DERM-MET-PSO-2026-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (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.

  8 weeks after starting treatment

Study Arms (2)

Metformin

ACTIVE COMPARATOR

patient with mild psoriasis with PASI less than 10% will receive topical metformin 30% cream twice daily

Drug: Topical metformin 30% cream

Placebo

PLACEBO COMPARATOR

patients with mild psoriasis vulgaris will receive placebo cream twice daily

Drug: Placebo

Interventions

Placebo DRUG

a plain similar cream (without metformin) will be prepared as a placebo.

Placebo

Topical metformin 30% cream DRUG

Metformin 30% loaded cream will be prepared using stearic acid as a lipid phase for group 1.

Metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 02, Egypt

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Yasmine A Obaid, MSc

CONTACT

02-01270047877; yasmeenahmed013@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)