- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01423383
Epidemiology Study of Keloid
October 17, 2016 updated by: Tirgan, Michael H., M.D.
Although keloid is a very common condition; there are no statistics as to its true incidence and prevalence, neither in United States, nor elsewhere in the world.
This trial intends to capture epidemiological data about this disease in a large population sample.
Study Overview
Status
Unknown
Conditions
Detailed Description
The purpose of current trial is to establish a robust database of incidence and prevalence of keloid, as well as prevalence of familial keloid, in various ethnic groups.
Study sample size is 100,000 random individuals who will fill out either a web survery or a paper questionnaire.
Study Type
Observational
Enrollment (Anticipated)
100000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael H. Tirgan, MD
- Phone Number: (212) 874 4200
- Email: htirgan@aol.com
Study Locations
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New York
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New York, New York, United States, 10023
- Recruiting
- Michael H. Tirgan, MD
-
Contact:
- Michael H. Tirgan, MD
- Phone Number: 212-874-4200
- Email: htirgan@aol.com
-
Principal Investigator:
- Michael H. Tirgan, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
General population will be sampled randomly
Description
Inclusion Criteria:
- Informed consent
- Age above 18 to answer the survey questions
- Parents shall respond on behalf of their minor children
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Random Populations
The aim of this study is to determine the prevalence and incidence of keloid in large populations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of various clinical findings will be determined at the end of Survey.
Time Frame: Two Years
|
This will be a prospective online and paper based survey with an estimated 100,000 responders participating in two years.
Statistics will be descriptive.
The prevalence of various clinical findings will be determined at the end of Survey.
Findings will be correlated with the source of the data, online, or paper questionnaire, as well as the locations where the paper questionnaires surveys were placed.
|
Two Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Michael H. Tirgan, MD, St. Luke's-Roosevelt Hospital Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
August 23, 2011
First Submitted That Met QC Criteria
August 24, 2011
First Posted (Estimate)
August 25, 2011
Study Record Updates
Last Update Posted (Estimate)
October 18, 2016
Last Update Submitted That Met QC Criteria
October 17, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tirgan 11-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keloid
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CHA UniversityCompletedHypertrophic or Keloid ScarsKorea, Republic of
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Queen Mary University of LondonWithdrawn
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SolitonEmergent Clinical Consulting, LLCCompleted
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Sensus HealthcareUnknownKeloid ScarUnited States
-
Sensus HealthcareUnknown
-
University of UlmCompleted
-
NYU Langone HealthCompleted
-
Northwestern UniversityCompleted
-
Our Lady of the Lake HospitalLouisiana State University Health Sciences Center in New OrleansCompletedPost-Surgical Injection With Triamcinolone Versus Triamcinolone/Fluorouracil in Treatment of KeloidsKeloid | Keloid Scar Following SurgeryUnited States
-
National Cheng-Kung University HospitalTainan Hospital, Ministry of Health and WelfareActive, not recruiting