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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | patient with mild psoriasis with PASI less than 10% will receive topical metformin 30% cream twice daily |
|
| Placebo | Placebo Comparator | patients with mild psoriasis vulgaris will receive placebo cream twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical metformin 30% cream | Drug | Metformin 30% loaded cream will be prepared using stearic acid as a lipid phase for group 1. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasmine A Obaid, MSc | Contact | 02-01270047877 | yasmeenahmed013@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Cairo Governorate | 02 | Egypt |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | a plain similar cream (without metformin) will be prepared as a placebo. |
|