Determining the extent of liver scarring in patients with psoriasis using a non-invasive scan and assessing the relationship between liver scarring and other potential risk factors for liver damage including methotrexate

Investigation of the prevalence of liver fibrosis in patients with psoriasis using transient elastography and evaluation of the relationship between liver fibrosis and risk factors for liver fibrosis including methotrexate

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15878562

Enrollment

250

Registered

2020-06-17

Start date

2020-06-08

Completion date

Unknown

Last updated

2024-06-03

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

Conditions

Liver fibrosis in psoriasis Digestive System Fibrosis and cirrhosis of liver

Interventions

The study will be a cross-sectional design. Patients with chronic plaque psoriasis diagnosed by a dermatologist with a PASI score of at least 5 at any time will be invited to join the study. A patient

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults > = 18 years of age 2. Ability to consent 3. Chronic plaque psoriasis diagnosed by a dermatologist with a PASI > = 5 at anytime

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Potential participants who may have difficulties in adequately understanding written or verbal information in English

Design outcomes

Primary

Measure	Time frame
1. Cumulative dose of methotrexate within 6 months of recruitment, calculated from data collected to identify weekly doses each patient received (mg) over time and adding these up to reach a total dose in gram for every patient 2. Liver stiffness measured using Fibroscan within 12 months of recruitment	—

Secondary

Measure	Time frame
1. Demographics, weight (kg), waist (cm), height (cm), blood pressure (mm/Hg) measured at baseline/within 6 months of recruitment 2. Risk factors for liver disease (HbA1c, triglycerides (mmol/L), HDL (mmol/L), LDL (mmol/L), cholesterol (mmol/L), platelets, liver function tests, ALT, worst ever ALT in the past year, AST, worst ever AST in the past year, ALT/AST ratio, albumin, procollagen three peptide (PIIINP) – worst value), measured using blood samples within 6 months of recruitment 3. Psoriasis severity measured using Psoriasis Area Severity Index (PASI) (score ranges: 0-72) at baseline and worst ever 4. Impact of skin disease on the quality of life measured using Dermatology Life Quality Index (DLQI) (score ranges: 0-30) at baseline and worst ever 5. Alcohol use measured using AUDIT Score at baseline and within 6 months of recruitment 6. Metabolic syndrome, defined as waist =94 cm (men) or =80 cm (women), and =2 of: 6.1. =5.6 mmol/L (100 mg/dL) or diagnosed diabetes 6.2. <1.0 mmol/L (40 mg/dL) (men); <1.3 mmol/L (50 mg/dL) (women) or drug treatment for low HDL cholesterol 6.3. =1.7 mmol/L (150 mg/dL) or drug treatment for high triglycerides 6.4. =130/85 mmHg or drug treatment for hypertension Measured within 6 months of recruitment 7. Liver fibrosis/scarring measured using FIB 4 score within 6 months of recruitment 8. Fatty liver measured using NAFLD score within 6 months of recruitment	—

Measure

Time frame

1. Demographics, weight (kg), waist (cm), height (cm), blood pressure (mm/Hg) measured at baseline/within 6 months of recruitment 2. Risk factors for liver disease (HbA1c, triglycerides (mmol/L), HDL (mmol/L), LDL (mmol/L), cholesterol (mmol/L), platelets, liver function tests, ALT, worst ever ALT in the past year, AST, worst ever AST in the past year, ALT/AST ratio, albumin, procollagen three peptide (PIIINP) – worst value), measured using blood samples within 6 months of recruitment 3. Psoriasis severity measured using Psoriasis Area Severity Index (PASI) (score ranges: 0-72) at baseline and worst ever 4. Impact of skin disease on the quality of life measured using Dermatology Life Quality Index (DLQI) (score ranges: 0-30) at baseline and worst ever 5. Alcohol use measured using AUDIT Score at baseline and within 6 months of recruitment 6. Metabolic syndrome, defined as waist =94 cm (men) or =80 cm (women), and =2 of: 6.1. =5.6 mmol/L (100 mg/dL) or diagnosed diabetes 6.2. <1.0 mmol/L (40 mg/dL) (men); <1.3 mmol/L (50 mg/dL) (women) or drug treatment for low HDL cholesterol 6.3. =1.7 mmol/L (150 mg/dL) or drug treatment for high triglycerides 6.4. =130/85 mmHg or drug treatment for hypertension Measured within 6 months of recruitment 7. Liver fibrosis/scarring measured using FIB 4 score within 6 months of recruitment 8. Fatty liver measured using NAFLD score within 6 months of recruitment

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026