New Topical Treatment in Plaque Psoriasis

NCT ID: NCT07113756

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

Brief 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

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group (1) will use 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

Group Type: ACTIVE_COMPARATOR

topical metformin 30% cream

Intervention Type: 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

group(2) topical betamethasone valerate .1% cream.

each patient will use topical betamethasone valerate .1% cream twice daily for 12 weeks.

Group Type: PLACEBO_COMPARATOR

betamethasone valerate.1% cream

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Sherein Gamal Abdellah

assistant lecturer of dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

shereen G gamal, Assistant lecturer

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Central Contacts

shereen G AbdEllah, assistant lecturer

Role: CONTACT

shereengamal157@yahoo.com

01033835302

Other Identifiers

Soh-Med-25-2-2MD

Identifier Type: -

Identifier Source: org_study_id