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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07375654
Acronym
CsA/Met
Enrollment
32
Registered
2026-01-29
Start date
2024-12-19
Completion date
2025-11-04
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

psoriasis, cyclosporin, metformin

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.

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.

Interventions

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

DRUGMetformin (500 mg Twice a day)

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

* 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome Measure 1 Change in Psoriasis Area and Severity Index (PASI)Baseline (Pretreatment) ,Post-treatment(At 3 months),At 6 monthsComparison 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)
Primary Outcome Measure 2 Change in Body Surface Area (BSA)Baseline (pretreatment), 3 months, and 6 months post-treatmentComparison 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)
Primary Outcome Measure 3 Change in Dermatology Life Quality Index (DLQI)Baseline (pretreatment), 3 months, and 6 months post-treatmentComparison 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)

Secondary

MeasureTime frameDescription
Patient satisfaction .Post treatment(AT 3 months)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.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMarwa Salah El-Mesidy, Assistant Professor

Cairo University

PRINCIPAL_INVESTIGATORAya Mohamed Fahim, Assistant Professor

Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026