Combined Use of Cyclosporine and Metformin in Treatment of Psoriasis vs Cyclosporine Alone (CsA/Met)

A Comparative Study on the Efficacy of The Combined Use of Cyclosporine and Metformin in the Treatment of Psoriasis vs Cyclosporine Alone

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Cyclosporin (CSA); Drug: Metformin (500 mg Twice a day)

Detailed Description

Psoriasis is a chronic, immune-mediated inflammatory skin disease characterized by erythematous, scaly plaques and a relapsing course. It has a significant negative impact on patients' quality of life and is frequently associated with metabolic comorbidities, including insulin resistance and obesity. Management of moderate to severe psoriasis often requires systemic therapy to achieve adequate disease control.

Cyclosporine is a well-established systemic immunosuppressive drug used in the treatment of moderate to severe psoriasis due to its rapid onset of action and effectiveness in reducing disease severity. Its mechanism involves inhibition of T-cell activation and cytokine production. However, long-term use of cyclosporine is limited by potential adverse effects, particularly nephrotoxicity, hypertension, and metabolic disturbances. Therefore, strategies to enhance its efficacy while potentially allowing dose reduction are of clinical importance.

Metformin is an oral hypoglycemic agent widely used in the management of type 2 diabetes mellitus. Beyond its glucose-lowering effect, metformin has demonstrated anti-inflammatory, immunomodulatory, and antiproliferative properties. Recent evidence suggests that metformin may play a beneficial role in inflammatory and immune-mediated diseases, including psoriasis, through modulation of inflammatory cytokines and improvement of insulin resistance, which is commonly observed in psoriatic patients.

This study is designed as a comparative clinical study to evaluate the efficacy of combined therapy using cyclosporine and metformin versus cyclosporine monotherapy in the treatment of psoriasis. The primary objective is to assess whether the addition of metformin enhances the clinical response compared to cyclosporine alone. Treatment efficacy will be evaluated using standardized clinical assessment tools for psoriasis severity, along with monitoring of treatment safety and tolerability.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, Egypt 02002
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cyclosporin (CSA); Group A: (16) patients will receive Cyclosporine (dose 3 mg/kg),orally twice per day for 3months	Drug: Cyclosporin (CSA); Cyclosporine (dose 3 mg/kg),orally twice per day for 3 months
Active Comparator: Cyclosporin plus Metformin; Group B: (16) patients will receive Cyclosporine(3mg/kg/day), orally and Metformin (500 mg twice daily) ,orally for 3 months	Drug: Cyclosporin (CSA); Cyclosporine (dose 3 mg/kg),orally twice per day for 3 months; Drug: Metformin (500 mg Twice a day); Metformin (500 mg twice daily),orally for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction .	Patients' Global Satisfaction Scale ranging from -1 to 3. Patient satisfaction is graded as excellent (3), moderately satisfied (2), poorly satisfied (1), not satisfied (0), or condition worsened (-1), with higher scores indicating greater patient satisfaction and better clinical outcome.	Post treatment(AT 3 months)

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Marwa Salah El-Mesidy, Assistant Professor, Cairo University; Principal Investigator: Aya Mohamed Fahim, Assistant Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Actual): October 4, 2025
• Study Completion (Actual): November 4, 2025

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 24, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: metformin; psoriasis; cyclosporin
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; Peptides; Amino Acids, Peptides, and Proteins; Organic Chemicals; Polycyclic Compounds; Macrocyclic Compounds; Biguanides; Guanidines; Amidines; Peptides, Cyclic; Cyclosporins; Metformin; Cyclosporine
• Other Study ID Numbers: MS-308-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No