Psoriasis VulgarisNCT02990624
Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy
A study testing PUVA in people with Psoriasis Vulgaris, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- PUVA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Disease affecting > 10% body surface area
- Patient willing to commit to 3 sessions weekly for 3-6 months without interruption
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dermatology department - faculty of medicine- Cairo University
Cairo
About this study
Official title: Effect of Photochemotherapy on Cardiometabolic Markers in Patients With Psoriasis With and Without Atherosclerosis
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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- PUVA
- Keywords
- psoriasis, photochemotherapy, atherosclerosis, metabolic syndrome, cardiovascular risk
- Medical subject headings
- Psoriasis, Atherosclerosis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUVARadiation
36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly
| Study group | Role | What they receive |
|---|---|---|
| High risk group | Active comparator | Patients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly Receives: 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 Receives: Radiation: PUVA |
| Control group | No intervention | Age-matching apparently normal individuals will receive no interventions but will perform investigational tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Comparison between both risk groups as regards the number of patients with metabolic syndrome
Measured: 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
Comparison between both risk groups in the amount of change between baseline level and EOS level of waist circumference
Measured: 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
Comparison between both risk groups in the amount of change between baseline level and EOS level of arterial blood pressure
Measured: 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
Comparison between both risk groups in the amount of change between baseline level and EOS level of blood sugar
Measured: 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
Comparison between both risk groups in the amount of change between baseline level and EOS level of serum lipids
Measured: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
Atherosclerotic changes in the high risk group in response to PUVA
comparison of duplex arteriography findings in the high risk group between before and after treatment
Measured: end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy)
Correlation between cutaneous response and systemic response to photochemotherapy in both risk groups
Correlation between PASI score after treatment and other parameters of systemic response (hs-CRP, ox-LDL, metabolic syndrome components)
Measured: day 0 to end of 12 weeks (end of 36 sessions, 3 sessions weekly of photochemotherapy) and/or clinical cure whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Suzanne Galal Hafez, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990624
- Sponsor's protocol ID
- CVR in UV phototherapy
- Status last verified
- Dec 2016
- First submitted
- 29 Nov 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photochemotherapy on Cardiometabolic Markers in Patients With Psoriasis With and Without Atherosclerosis
- ClinicalTrials.gov ID
- NCT02990624
- Acronym / sponsor ID
- CVR in UV phototherapy
- Conditions
- Psoriasis Vulgaris
- Keywords
- psoriasis, photochemotherapy, atherosclerosis, metabolic syndrome, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High risk group | Active comparator | Radiation: PUVAPatients with psoriasis and atherosclerosis will receive PUVA therapy for 36 sessions divided as 3 sessions weekly |
| Low risk group | Active comparator | Radiation: PUVAPatients with psoriasis but no atherosclerosis detected, will receive PUVA therapy for 36 sessions divided as 3 sessions weekly |
| Control group | No intervention | –Age-matching apparently normal individuals will receive no interventions but will perform investigational tests. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Disease affecting > 10% body surface area
- Patient willing to commit to 3 sessions weekly for 3-6 months without interruption
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUVA36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly | Radiation | High risk group, Low risk group |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PUVA in people with Psoriasis Vulgaris, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.