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Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy

NCT ID: NCT02990624

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis Vulgaris

Keywords

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psoriasis photochemotherapy atherosclerosis metabolic syndrome cardiovascular risk

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High risk group

Patients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly

Group Type ACTIVE_COMPARATOR

PUVA

Intervention Type RADIATION

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

Low risk group

Patients with psoriasis but no atherosclerosis detected, will receive PUVA therapy for 36 sessions divided as 3 sessions weekly

Group Type ACTIVE_COMPARATOR

PUVA

Intervention Type RADIATION

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

Control group

Age-matching apparently normal individuals will receive no interventions but will perform investigational tests.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PUVA

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Vanessa Suzanne Galal Hafez

Lecturer of dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dermatology department - faculty of medicine- Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CVR in UV phototherapy

Identifier Type: -

Identifier Source: org_study_id