Vitiligo VulgarisNCT01206374
Questionnaire and Laboratory Data on Vitiligo Vulgaris
An observational study of Vitiligo Vulgaris, run by St. Luke's-Roosevelt Hospital Center at 2 sites in United States.
Trial summary
Vitiligo vulgaris is an autoimmune disorder that causes loss of pigmentation over the skin, hair and mucous membranes (e.g. lips, nose, genitals). While genes have been identified that are thought to be required for development of vitiligo, only 5-10% of relatives develop disease. 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
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Sep 2014
- 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: All patients willing to sign consent, complete questionnaire and/ or laboratory studies.
Who may be able to join
- Diagnosis of Vitiligo Vulgaris
- Ability to sign consent
Who cannot join
- Pregnant
- Inability to sign consent
- Inability to complete questionnaire
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Dermatology, Beth Israel Medical Center
New York, New York, 10003
Department of Dermatology, St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
Official title: Demographic and Laboratory Data Collection for Patients With Vitiligo Vulgaris
Vitiligo vulgaris is an autoimmune disorder that causes loss of pigmentation over the skin, hair and mucous membranes (e.g. lips, nose, genitals). While genes have been identified that are thought to be required for development of vitiligo, only 5-10% of relatives develop disease. The triggers for disease onset have not yet been identified. The intent of this study is to research trends in laboratory data, social and medical history that may be contributory to vitiligo onset, location of disease, course of illness and response to therapy.
Read the detailed description
Patients who participate in this study will be asked to complete a survey and have blood/ laboratory testing performed that relates or may relate to the diagnosis of vitiligo.
- Conditions
- Vitiligo Vulgaris
- Keywords
- Vitiligo Vulgaris
- Medical subject headings
- Vitiligo
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life disturbances in people with vitiligo
dermatology life quality indices were you used and correlated with location of disease
Measured: point prevalence
Secondary outcomes (1)
self-reporting of vitiligo disease symptoms and history
Correlation of the patient survey response with chart documentation was performed.
Measured: single survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionSep 2014
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Medical Center
- Responsible party
- Sponsor
- Investigators
- Nanette Silverberg, MD, Principal investigator, StLukesNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206374
- Sponsor's protocol ID
- 10-027SLRHC
- Status last verified
- May 2015
- First submitted
- 20 Sep 2010
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Silverberg NB. Update on childhood vitiligo. Curr Opin Pediatr. 2010 Aug;22(4):445-52. doi: 10.1097/MOP.0b013e32833b6ac3.
PubMed 20616733Silverberg JI, Silverberg AI, Malka E, Silverberg NB. A pilot study assessing the role of 25 hydroxy vitamin D levels in patients with vitiligo vulgaris. J Am Acad Dermatol. 2010 Jun;62(6):937-41. doi: 10.1016/j.jaad.2009.11.024.
PubMed 20466170Pagovich OE, Silverberg JI, Freilich E, Silverberg NB. Thyroid abnormalities in pediatric patients with vitiligo in New York City. Cutis. 2008 Jun;81(6):463-6.
PubMed 18666385
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic and Laboratory Data Collection for Patients With Vitiligo Vulgaris
- ClinicalTrials.gov ID
- NCT01206374
- Acronym / sponsor ID
- 10-027SLRHC
- Conditions
- Vitiligo Vulgaris
- Keywords
- Vitiligo Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- Beth Israel Medical Center
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 Sep 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.
Vitiligo vulgaris is an autoimmune disorder that causes loss of pigmentation over the skin, hair and mucous membranes (e.g. lips, nose, genitals). While genes have been identified that are thought to be required for development of vitiligo, only 5-10% of relatives develop disease. The triggers for disease onset have not yet been identified. The intent of this study is to research trends in laboratory data, social and medical history that may be contributory to vitiligo onset, location of disease, course of illness and response to therapy.
Detailed description
Patients who participate in this study will be asked to complete a survey and have blood/ laboratory testing performed that relates or may relate to the diagnosis of vitiligo.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients willing to sign consent, complete questionnaire and/ or laboratory studies.
Key inclusion criteria (2 listed)
- Diagnosis of Vitiligo Vulgaris
- Ability to sign consent
Key exclusion criteria (3 listed)
- Pregnant
- Inability to sign consent
- Inability to complete questionnaire
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
Quality of life disturbances in people with vitiligo
Time frame: point prevalence
dermatology life quality indices were you used and correlated with location of disease
1 secondary outcome
self-reporting of vitiligo disease symptoms and history
Time frame: 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 25 May 2015.
- Background: PubMed 20616733Silverberg NB. Update on childhood vitiligo. Curr Opin Pediatr. 2010 Aug;22(4):445-52. doi: 10.1097/MOP.0b013e32833b6ac3.
- Background: PubMed 20466170Silverberg JI, Silverberg AI, Malka E, Silverberg NB. A pilot study assessing the role of 25 hydroxy vitamin D levels in patients with vitiligo vulgaris. J Am Acad Dermatol. 2010 Jun;62(6):937-41. doi: 10.1016/j.jaad.2009.11.024.
- Background: PubMed 18666385Pagovich OE, Silverberg JI, Freilich E, Silverberg NB. Thyroid abnormalities in pediatric patients with vitiligo in New York City. Cutis. 2008 Jun;81(6):463-6.
Related trials for Vitiligo Vulgaris
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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
StLukesNY
2 sites 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 2 sites 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 2 inclusion and 3 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 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quality of life disturbances in people with vitiligo (time frame: point prevalence). 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 NCT01206374, 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 25 May 2015.