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Completed

NCT Number: NCT02990624

Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy

Ultraviolet (UV) phototherapy is a standard treatment for many inflammatory dermatological diseases, including psoriasis. The systemic effects of UV phototherapy are still not well studied. There are several factors that may affect patient's cardiovascular (CV) risk during UV phototherapy. Atherosclerosis is now known to have an inflammatory origin and to be frequently associated with psoriasis. In this study the investigators aim at studying the effect of psoralen-UVA phototherapy on several biomarkers of CV risk in patients with psoriasis with or without atherosclerosis.

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Key information

Conditions

Psoriasis Vulgaris Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology department - faculty of medicine- Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Disease affecting > 10% body surface area
  • Patient willing to commit to 3 sessions weekly for 3-6 months without interruption

Exclusion criteria

  • Disease severity less than 10% body surface area
  • Patients unable to commit for therapeutic schedule due to work or residence issues.
  • pregnant and lactating females
  • photosensitive dermatoses

Treatment and study plan

PUVA

Radiation

36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly

Primary outcomes

  1. Comparative change in photoinduced oxidation and related change in cardiovascular risk between both risk groups in response to photochemotherapy

    Time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first

    Comparison between both risk groups in the amount of change between baseline level and end of study level of oxidized low density lipoprotein

Secondary outcomes

  1. comparative number of patients with metabolic syndrome after therapy in both groups

    Time frame: end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first

    Comparison between both risk groups as regards the number of patients with metabolic syndrome

  2. Comparative changes in metabolic syndrome component 1: waist circumference

    Time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first

    Comparison between both risk groups in the amount of change between baseline level and EOS level of waist circumference

  3. Comparative changes in metabolic syndrome component 2: arterial blood pressure

    Time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first

    Comparison between both risk groups in the amount of change between baseline level and EOS level of arterial blood pressure

  4. Comparative changes in metabolic syndrome component 3: blood sugar

    Time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first

    Comparison between both risk groups in the amount of change between baseline level and EOS level of blood sugar

  5. Comparative changes in metabolic syndrome component 4: serum lipids

    Time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first

    Comparison between both risk groups in the amount of change between baseline level and EOS level of serum lipids

  6. Atherosclerotic changes in the high risk group in response to PUVA

    Time frame: end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy)

    comparison of duplex arteriography findings in the high risk group between before and after treatment

  7. Correlation between cutaneous response and systemic response to photochemotherapy in both risk groups

    Time frame: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first

    Correlation between PASI score after treatment and other parameters of systemic response (hs-CRP, ox-LDL, metabolic syndrome components)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Photochemotherapy on Cardiometabolic Markers in Patients With Psoriasis With and Without Atherosclerosis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 13, 2016
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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