Vitiligo VulgarisNCT01401374
Online Health Survey of Patients With Vitiligo Vulgaris/ Online Survey of Pediatric Patients With Vitiligo
An observational study of Vitiligo Vulgaris, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The study is an on-line survey posted on survey monkey that addresses some demographic and environmental issues that could potentially relate to vitiligo vulgaris onset or disease exacerbation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vitiligo Vulgaris
- How many people
- 3,258 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals self-reporting vitiligo vulgaris and controls who do not have vitiligo vulgaris
Who may be able to join
- Ability to complete survey
Who cannot join
- Inability to complete survey
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
The study is an on-line survey posted on survey monkey that addresses some demographic and environmental issues that could potentially relate to vitiligo vulgaris onset or disease exacerbation.
Read the detailed description
The survey is designed to look at some issues that are pertinent to individuals with vitiligo, including access to care, severity of disease, under-reported disease activity, causative and exacerbating factors and co-morbid illnesses.
- Conditions
- Vitiligo Vulgaris
- Keywords
- Vitiligo Vulgaris, Autoimmunity, Thyroid Disease
- Medical subject headings
- Vitiligo, Autoimmune Diseases, Thyroid Diseases
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 |
|---|---|---|
| Vitiligo Patients | patients with vitiligo vulgaris | |
| Controls | Individuals without vitiligo vulgaris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Disease State in Vitiligo with Clinical and Psychological Measures
Measured: Self-reported retrospective single survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vitiligo VulgarisStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 3,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nanette Silverberg, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401374
- Sponsor's protocol ID
- 10-148/10-149x
- Status last verified
- Apr 2017
- First submitted
- 21 Jul 2011
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Silverberg JI, Reja M, Silverberg NB. Regional variation of and association of US birthplace with vitiligo extent. JAMA Dermatol. 2014 Dec;150(12):1298-305. doi: 10.1001/jamadermatol.2014.899.
PubMed 25006795Silverberg JI, Silverberg NB. Quality of life impairment in children and adolescents with vitiligo. Pediatr Dermatol. 2014 May-Jun;31(3):309-18. doi: 10.1111/pde.12226. Epub 2013 Oct 18.
PubMed 24304125Silverberg JI, Silverberg NB. Association between vitiligo extent and distribution and quality-of-life impairment. JAMA Dermatol. 2013 Feb;149(2):159-64. doi: 10.1001/jamadermatol.2013.927.
PubMed 23560296
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Health Survey of Patients With Vitiligo Vulgaris/ Online Survey of Pediatric Patients With Vitiligo
- ClinicalTrials.gov ID
- NCT01401374
- Acronym / sponsor ID
- 10-148/10-149x
- Conditions
- Vitiligo Vulgaris
- Keywords
- Vitiligo Vulgaris, Autoimmunity, Thyroid Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,258 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Jul 2011 (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 study is an on-line survey posted on survey monkey that addresses some demographic and environmental issues that could potentially relate to vitiligo vulgaris onset or disease exacerbation.
Detailed description
The survey is designed to look at some issues that are pertinent to individuals with vitiligo, including access to care, severity of disease, under-reported disease activity, causative and exacerbating factors and co-morbid illnesses.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitiligo Patients | – | –patients with vitiligo vulgaris |
| Controls | – | –Individuals without vitiligo vulgaris |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals self-reporting vitiligo vulgaris and controls who do not have vitiligo vulgaris
Key inclusion criteria (1 listed)
- Ability to complete survey
Key exclusion criteria (1 listed)
- Inability to complete survey
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
Correlation of Disease State in Vitiligo with Clinical and Psychological Measures
Time frame: Self-reported retrospective single survey
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 10 Apr 2017.
- Derived from this study: PubMed 25006795Silverberg JI, Reja M, Silverberg NB. Regional variation of and association of US birthplace with vitiligo extent. JAMA Dermatol. 2014 Dec;150(12):1298-305. doi: 10.1001/jamadermatol.2014.899.
- Derived from this study: PubMed 24304125Silverberg JI, Silverberg NB. Quality of life impairment in children and adolescents with vitiligo. Pediatr Dermatol. 2014 May-Jun;31(3):309-18. doi: 10.1111/pde.12226. Epub 2013 Oct 18.
- Derived from this study: PubMed 23560296Silverberg JI, Silverberg NB. Association between vitiligo extent and distribution and quality-of-life impairment. JAMA Dermatol. 2013 Feb;149(2):159-64. doi: 10.1001/jamadermatol.2013.927.
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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.
Nanette Silverberg, MD principal investigator
St. Luke's-Roosevelt Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo Vulgaris, run by St. Luke's-Roosevelt Hospital Center 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 1 inclusion and 1 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 10 Apr 2017. 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 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?
Correlation of Disease State in Vitiligo with Clinical and Psychological Measures (time frame: Self-reported retrospective single survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01401374, which also lists 3 linked publications.
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 10 Apr 2017.