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Psoriasis is a chronic, recurring, immune-mediated papulosquamous condition The etiology of psoriasis is complex and not fully understood Though many treatment options are available for plaque psoriasis, each has its limitations and side effects. Therefore, the need for an effective topical agent that delivers the drug efficiently into the target site with minimal systemic side effects remains an aim in itself.Metformin is a derivative of biguanide that is the most widely used as an oral antihyperglycemic agent for the control of diabetes mellitus. In addition to its hypoglycaemic effect, metformin can serve as an anti-inflammatory agent. Metformin has been demonstrated to suppress proliferation in keratinocytes by blocking the mitogen-activated protein kinase pathway (MAPK) (25). Hence, metformin may play an important role in the reducing pathogenesis of psoriasis by anti-inflammatory, anti-proliferative, and anti- angiogenic effects .The topical form of metformin has been used in regenerative medicine (33), treatment of acne (34), adjuvant treatment for psoriasis (35), neo-adjuvant therapy for squamous cell carcinoma (36), and treatment of pigmentary disorders as an alternative to hydroquinone (37). The aim of the study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group (1) will use topical metformin 30% cream | Active Comparator | each patient will use topical metformin 30% cream twice daily for 12 weeks. o Preparation of metformin 30% cream: Weighing 30 gm standard metformin ( E. Merck ) supplied by chemtech. Using digital balance then Grinding the powder by pestle & Morter then Adding 30 ml propylene glycol and alcohol to reach a total 100 gm weight then adding parabens mix as preservative with 0.5 gm then mix thoroughly followed by Levegating & mixing then divide to smaller well tighten closure with labels |
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| group(2) topical betamethasone valerate .1% cream. | Placebo Comparator | each patient will use topical betamethasone valerate .1% cream twice daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical metformin 30% cream | Drug | each patient will use topical metformin 30% cream twice daily for 12 weeks. o Preparation of metformin 30% cream: Weighing 30 gm standard metformin ( E. Merck ) supplied by chemtech. Using digital balance then Grinding the powder by pestle & Morter then Adding 30 ml propylene glycol and alcohol to reach a total 100 gm weight then adding parabens mix as preservative with 0.5 gm then mix thoroughly followed by Levegating & mixing then divide to smaller well tighten closure with labels |
| Measure | Description | Time Frame |
|---|---|---|
| clinical improvement in psoriatic skin lesions | clinical evaluation using PASI score to assess improvement before and treatment | at the end of treatment (12 weeks) and 3 months after stoppage of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shereen G AbdEllah, assistant lecturer | Contact | 01033835302 | shereengamal157@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| shereen G gamal, Assistant lecturer | Sohag University | Principal Investigator |
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individual participant data will not be shared due to patient privacy concerns and lack of consent for external sharing
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| betamethasone valerate.1% cream | Drug | each patient (age, sex and BMI matched) will use topical betamethasone valerate 0.1% cream twice daily for 12 weeks. o Manufactured by Egyptian international pharmaceutical industries co. E.I.P.I.C.O. and will be purchased from local pharmacy, Sohag, Egypt. |
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