Combined Use of Cyclosporine and Metformin in Treatment of Psoriasis vs Cyclosporine Alone

NCT07375654 | Completed Phase 1 DMC

• 1 other identifier: MS-308-2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a comparative clinical study evaluating the efficacy of combined therapy using cyclosporine and metformin versus cyclosporine alone in the treatment of psoriasis. Psoriasis is a chronic inflammatory skin disease that often requires systemic therapy in moderate to severe cases. Cyclosporine is an effective immunosuppressive agent; however, its long-term use is limited by potential adverse effects. Metformin, a commonly used antidiabetic drug, has shown anti-inflammatory and immunomodulatory properties, which may enhance treatment outcomes in psoriasis. This study aims to assess whether adding metformin to cyclosporine improves clinical response compared to cyclosporine monotherapy.

Conditions

Psoriasis

Keywords

psoriasis; cyclosporin; metformin

Outcome Measures

Primary Outcomes (3)

• Primary Outcome Measure 1 Change in Psoriasis Area and Severity Index (PASI)

  Comparison of PASI scores before and after treatment within each group and between both treatment groups. Unit of Measure: PASI score Scale: 0-72 (higher scores indicate more severe psoriasis)

  Baseline (Pretreatment) ,Post-treatment(At 3 months),At 6 months

• Primary Outcome Measure 2 Change in Body Surface Area (BSA)

  Comparison of the percentage of body surface area affected by psoriasis before and after treatment within each group and between both treatment groups. Unit of Measure: Percentage of body surface area (%) Scale: 0-100% (higher percentages indicate greater skin involvement)

  Baseline (pretreatment), 3 months, and 6 months post-treatment

• Primary Outcome Measure 3 Change in Dermatology Life Quality Index (DLQI)

  Comparison of DLQI scores before and after treatment within each group and between both treatment groups. Unit of Measure: DLQI score Scale: 0-30 (higher scores indicate greater impairment of quality of life)

  Baseline (pretreatment), 3 months, and 6 months post-treatment

Secondary Outcomes (1)

• Patient satisfaction .

  Post treatment(AT 3 months)

Study Arms (2)

Cyclosporin (CSA)

ACTIVE COMPARATOR

Group A: (16) patients will receive Cyclosporine (dose 3 mg/kg),orally twice per day for 3months

Drug: Cyclosporin (CSA)

Cyclosporin plus Metformin

ACTIVE COMPARATOR

Group B: (16) patients will receive Cyclosporine(3mg/kg/day), orally and Metformin (500 mg twice daily) ,orally for 3 months

Drug: Cyclosporin (CSA); Drug: Metformin (500 mg Twice a day)

Interventions

Metformin (500 mg Twice a day) DRUG

Metformin (500 mg twice daily),orally for 3 months

Cyclosporin plus Metformin

Cyclosporin (CSA) DRUG

Cyclosporine (dose 3 mg/kg),orally twice per day for 3 months

Cyclosporin (CSA); Cyclosporin plus Metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years old
• Patients of both genders
• Patients clinically diagnosed as moderate to severe psoriasis candidate for systemic treatment with Psoriasis Area Severity Index (PASI \>10), Body Surface Area (BSA\>10), Dermatology Life Quality Index (DLQI\>10).(Laura Salgado-Boquete et al., 2021).
• Patients with new active lesions and also patient with chronic lesions (with periods of remission and exacerbation)

You may not qualify if:

• Erythrodermic and pustular psoriasis.
• Patients with systemic illness ( renal, hepatic and uncontrolled hypertension ).
• Pregnant and lactating females.
• Patients receiving systemic treatment relevant to psoriasis within 3 months before enrollment into the study or topical treatment relevant to psoriasis within 1 month before.
• Patients with other dermatological conditions.
• Patients with high uric acid level .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt 02002, Egypt

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Cyclosporine; Metformin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Marwa Salah El-Mesidy, Assistant Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Aya Mohamed Fahim, Assistant Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology,Faculty of Medicine ,Cairo University

Model Details: * Patients will be divided randomly (by simple randomization) into 2 equal groups: Group A: (16) patients will receive Cyclosporine (dose 3 mg/kg). And group B: (16) patients will receive Cyclosporine and Metformin (500 mg twice daily). * The instruction to the both groups will be identical and they will receive the treatment for a total of 3 months.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 29, 2026
• Study Start: December 19, 2024
• Primary Completion: October 4, 2025
• Study Completion: November 4, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)