Psoriasis VulgarisNCT07516821
Efficacy of Topical Metformin in Psoriasis Vulgaris
A study testing Topical metformin 30% cream in people with Psoriasis Vulgaris, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Topical metformin 30% cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- Topical metformin 30% cream, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical metformin 30% creamDrug
Metformin 30% loaded cream will be prepared using stearic acid as a lipid phase for group 1.
PlaceboDrug
a plain similar cream (without metformin) will be prepared as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | patient with mild psoriasis with PASI less than 10% will receive topical metformin 30% cream twice daily Receives: Drug: Topical metformin 30% cream |
| Placebo | Placebo comparator | patients with mild psoriasis vulgaris will receive placebo cream twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment and comparison of tissue levels of interleukin 17 (IL - 17) between the topical metformin and placebo group.
Measured: 8 weeks after starting treatment
Comparison of percent PASI improvement from baseline between the topical metformin and placebo groups.
Measured: 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.
Measured: 8 weeks after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Ahmed Mahmoud Obaid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516821
- Sponsor's protocol ID
- DERM-MET-PSO-2026-01
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Metformin in Psoriasis Vulgaris: A Randomized, Double Blinded, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT07516821
- Acronym / sponsor ID
- DERM-MET-PSO-2026-01
- Conditions
- Psoriasis Vulgaris
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Topical metformin 30% creampatient with mild psoriasis with PASI less than 10% will receive topical metformin 30% cream twice daily |
| Placebo | Placebo comparator | Drug: Placebopatients with mild psoriasis vulgaris will receive placebo cream twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical metformin 30% creamMetformin 30% loaded cream will be prepared using stearic acid as a lipid phase for group 1. | Drug | Metformin |
| Placeboa plain similar cream (without metformin) will be prepared as a placebo. | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical metformin 30% cream in people with Psoriasis Vulgaris, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmine A Obaid, MSc (02-01270047877, yasmeenahmed013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.