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Efficacy of Topical Metformin in Psoriasis Vulgaris

ConditionPsoriasis Vulgaris
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: MetforminActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: