PsoriasisNCT02193919
A Single-Center, Prospective, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
An observational study of Psoriasis, run by Bagel, Jerry, M.D..
Trial summary
Weight loss may help psoriasis. Phototherapy helps psoriasis. Combining the two treatments may help even more. Determining if a high protein diet vs a low protein diet results in improving psoriais may help lead to future dietary effects on psoriasis therapy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to May 2008
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 patients, males, females, over 18 yo with moderate-to-severe psoriasis
Who may be able to join
- PSA greater 10
- BMI greater than 30
Who cannot join
- PSA less than 10
- less than 18 years old
About this study
Official title: A Single-Center, Prospective, Single-Blind, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
Weight loss may help psoriasis. Phototherapy helps psoriasis. Combining the two treatments may help even more. Determining if a high protein diet vs a low protein diet results in improving psoriais may help lead to future dietary effects on psoriasis therapy
- Conditions
- Psoriasis
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 placebo + UVB | cohort 1 placebo + UVB | |
| South Beach Diet + UVB | South Beach DIet + UVB | |
| Ornish Diet + UVB | Ornish Diet + UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does weight decrease the amount of UVB needed to clear psoriasis
3 cohorts, all get UVB thrice per week one cohort placebo diet one cohort south beach diet one cohort ornish diet I evaluated PASI 75 improvement within each cohort 0 Adverse Events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startMar 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagel, Jerry, M.D.
- Responsible party
- Principal investigator, Jerry Bagel MD, Bagel, Jerry, M.D.
- Investigators
- Jerry Bagel, Principal investigator, Psoriasis Treatment Center of Central New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193919
- Sponsor's protocol ID
- PO-001
- Status last verified
- Jul 2014
- First submitted
- 4 Feb 2013
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Single-Blind, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
- ClinicalTrials.gov ID
- NCT02193919
- Acronym / sponsor ID
- PO-001
- Conditions
- Psoriasis
- Keywords
- psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bagel, Jerry, M.D.
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 18 Jul 2014 (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.
Weight loss may help psoriasis. Phototherapy helps psoriasis. Combining the two treatments may help even more. Determining if a high protein diet vs a low protein diet results in improving psoriais may help lead to future dietary effects on psoriasis therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort 1 placebo + UVB | – | –cohort 1 placebo + UVB |
| South Beach Diet + UVB | – | –South Beach DIet + UVB |
| Ornish Diet + UVB | – | –Ornish Diet + UVB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients, males, females, over 18 yo with moderate-to-severe psoriasis
Key inclusion criteria (2 listed)
- PSA greater 10
- BMI greater than 30
Key exclusion criteria (2 listed)
- PSA less than 10
- less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Does weight decrease the amount of UVB needed to clear psoriasis
Time frame: 12 weeks
3 cohorts, all get UVB thrice per week one cohort placebo diet one cohort south beach diet one cohort ornish diet I evaluated PASI 75 improvement within each cohort 0 Adverse Events
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 18 Jul 2014.
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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.
Jerry Bagel principal investigator
Psoriasis Treatment Center of Central New Jersey
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Bagel, Jerry, M.D..
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 2 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 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Does weight decrease the amount of UVB needed to clear psoriasis (time frame: 12 weeks). 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 18 Jul 2014.