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New Topical Treatment in Plaque Psoriasis

NCT07113756 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-08-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

topical metformin 30% cream

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

DRUG

betamethasone valerate.1% cream

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.

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • shereen G gamal, Assistant lecturer · Sohag University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-12-01
Completion
2026-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07113756 on ClinicalTrials.gov