NCT02990624

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

1.4 years

First QC Date

November 29, 2016

Last Update Submit

December 8, 2016

Conditions

Psoriasis Vulgaris

Keywords

psoriasisphotochemotherapyatherosclerosismetabolic syndromecardiovascular risk

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (7)

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

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

  • Comparative changes in metabolic syndrome component 1: waist circumference

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

  • Comparative changes in metabolic syndrome component 2: arterial blood pressure

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

  • Comparative changes in metabolic syndrome component 3: blood sugar

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

  • Comparative changes in metabolic syndrome component 4: serum lipids

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

  • +2 more secondary outcomes

Study Arms (3)

High risk group

ACTIVE COMPARATOR

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

Radiation: PUVA

Low risk group

ACTIVE COMPARATOR

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

Radiation: PUVA

Control group

NO INTERVENTION

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

Interventions

PUVARADIATION

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

High risk groupLow risk group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology department - faculty of medicine- Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

PsoriasisAtherosclerosisMetabolic Syndrome

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of dermatology

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 13, 2016

Study Start

April 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

December 13, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)