PsoriasisNCT01137448
The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
A study testing Weight Loss in people with Psoriasis and Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect that weight loss has on the severity of psoriasis in obese subjects. Fifty obese (BMI equal to or greater than 30) patients with moderate to severe plaque psoriasis will be enrolled in a weight loss intervention program. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- A Body Mass Index (BMI) >/= 30
- Subject has plaque psoriasis
- A Psoriasis Area Severity Index (PASI) score >/= 10 or a total body surface area (BSA) affected by psoriasis >/= 10%
- Capable of reading, understanding, and signing a consent form
- Females of childbearing potential must have negative urine pregnancy test on Day 0, and agree to a medically effective method of birth control (as determined by the investigator)
Who cannot join
- Already participating in a study for weight loss or a study of other psoriasis treatments
- If they are on systemic therapy for their psoriasis
- Female subjects who are pregnant or planning to become pregnant
- Patients with a history of anorexia nervosa, bulimia, or other diseases that would make a weight loss program a risk to their health
- Subjects unable to comply with study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Dermatology Clinical Research
Houston, Texas, 77030
About this study
The purpose of this study is to evaluate the effect that weight loss has on the severity of psoriasis in obese subjects. Fifty obese (BMI equal to or greater than 30) patients with moderate to severe plaque psoriasis will be enrolled in a weight loss intervention program. The severity of their psoriasis will be reevaluated at month 3 and month 6 of the program to determine what effect weight loss has had on their psoriasis. Serum TNF-alpha will be measured at month 0 and month 6. The hypothesis that will be tested is that weight loss will lead to a significant improvement in the severity of psoriasis and a reduction in TNF-alpha levels.
- Being tested
- Weight Loss
- Keywords
- Psoriasis, Obesity
- Medical subject headings
- Psoriasis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight LossBehavioural
Subjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss | Experimental | Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling. Receives: Behavioral: Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of psoriasis
The Psoriasis Area Severity Index (PASI) is the most common validated psoriasis severity assessment tool used in clinical trials, and combines redness, thickness, and scaliness of skin lesions with the body surface area that is affected. Most clinical trials define moderate to severe psoriasis as a PASI score of greater than or equal to 10, or a total Body Surface Area (BSA) of greater than or equal to 10%.
Measured: 6 months
Secondary outcomes (1)
Serum TNF-alpha levels
Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: The site did not have enough funds to complete study arrengments and start to enrolling. The site was not able to enroll subjects.
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.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Adelaide Hebert, The University of Texas Health Science Center, Houston
- Investigators
- Adelaide Hebert, MD, Principal investigator, University of Texas Medical School - Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137448
- Sponsor's protocol ID
- 5T35DK007676-18
- Status last verified
- Dec 2013
- First submitted
- 3 Jun 2010
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
- ClinicalTrials.gov ID
- NCT01137448
- Acronym / sponsor ID
- 5T35DK007676-18
- Keywords
- Psoriasis, Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The site did not have enough funds to complete study arrengments and start to enrolling. The site was not able to enroll subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Jun 2010 (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.
The purpose of this study is to evaluate the effect that weight loss has on the severity of psoriasis in obese subjects. Fifty obese (BMI equal to or greater than 30) patients with moderate to severe plaque psoriasis will be enrolled in a weight loss intervention program. The severity of their psoriasis will be reevaluated at month 3 and month 6 of the program to determine what effect weight loss has had on their psoriasis. Serum TNF-alpha will be measured at month 0 and month 6. The hypothesis that will be tested is that weight loss will lead to a significant improvement in the severity of psoriasis and a reduction in TNF-alpha levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight Loss | Experimental | Behavioral: Weight LossSubjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >18 years of age
- A Body Mass Index (BMI) >/= 30
- Subject has plaque psoriasis
- A Psoriasis Area Severity Index (PASI) score >/= 10 or a total body surface area (BSA) affected by psoriasis >/= 10%
- Capable of reading, understanding, and signing a consent form
Key exclusion criteria (5 listed)
- Already participating in a study for weight loss or a study of other psoriasis treatments
- If they are on systemic therapy for their psoriasis
- Female subjects who are pregnant or planning to become pregnant
- Patients with a history of anorexia nervosa, bulimia, or other diseases that would make a weight loss program a risk to their health
- Subjects unable to comply with study protocol
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 |
|---|---|---|
| Weight LossSubjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months. | Behavioural | Weight Loss |
Primary outcome
Severity of psoriasis
Time frame: 6 months
The Psoriasis Area Severity Index (PASI) is the most common validated psoriasis severity assessment tool used in clinical trials, and combines redness, thickness, and scaliness of skin lesions with the body surface area that is affected. Most clinical trials define moderate to severe psoriasis as a PASI score of greater than or equal to 10, or a total Body Surface Area (BSA) of greater than or equal to 10%.
1 secondary outcome
Serum TNF-alpha levels
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
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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.
Adelaide Hebert, MD principal investigator
University of Texas Medical School - Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss in people with Psoriasis and Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 16 Dec 2013. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Severity of psoriasis (time frame: 6 months). 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 16 Dec 2013.