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NCT Number: NCT07113756

New Topical Treatment in Plaque Psoriasis

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:

* Assess the efficacy and the safety of topical metformin 30% cream compared with betamethasone valerate 0.1 % cream in the treatment of adult patients with mild and moderate plaque psoriasis. * Compare the efficacy of topical metformin 30% cream versus betamethasone valerate 0.1 % cream clinically, dermoscopically, histopathologically and immunohistochemically by measuring tissue level of IL17 in psoriatic skin lesions before and after treatment in all patients.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion Criteria:
  • Patients of both sexes aged ≥ 18 years, having clinical and dermoscopic finding of mild and moderate plaque psoriasis and did not receive any topical, phototherapy or systemic treatment in the last 3 months for psoriasis.
  • Exclusion Criteria:
  • Other types of psoriasis
  • Patient refusal.
  • Pregnant and lactating women.
  • Patients with other inflammatory or autoimmune skin diseases (atopic dermatitis, lichen planus, alopecia areata, cutaneous lupus erythromatosis, systemic sclerosis, rheumatoid arthritis, acne vulgaris, hidradinitis supprativa
  • Hypersensitivity to topical treatment.

Treatment and study plan

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

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.

Primary outcomes

  1. clinical improvement in psoriatic skin lesions

    Time frame: at the end of treatment (12 weeks) and 3 months after stoppage of treatment

    clinical evaluation using PASI score to assess improvement before and treatment

Study contacts

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

shereen G AbdEllah, assistant lecturer

CONTACT

[email protected]

01033835302

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Efficacy of Topical Metformin 30% Cream Versus Betamethasone Valerate 0.1% Cream in Treatment of Adult Patients With Plaque Psoriasis

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

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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