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NCT Number: NCT07516821

Efficacy of Topical Metformin in Psoriasis Vulgaris

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, 02, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical metformin 30% cream

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

  2. Comparison of percent PASI improvement from baseline between the topical metformin and placebo groups.

    Time frame: 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.

    Time frame: 8 weeks after starting treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Yasmine A Obaid, MSc

CONTACT

[email protected]

02-01270047877

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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