Epidemiology Study of Keloid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01423383
Recruitment Status : Recruiting
First Posted : August 25, 2011
Last Update Posted : October 18, 2016
Information provided by (Responsible Party):
Tirgan, Michael H., M.D.

Brief Summary:
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.

Condition or disease

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
Estimated Enrollment : 100000 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Epidemiology Study of Keloid
Study Start Date : September 2011
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2021

Random Populations
The aim of this study is to determine the prevalence and incidence of keloid in large populations.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
General population will be sampled randomly

Inclusion Criteria:

  1. Informed consent
  2. Age above 18 to answer the survey questions
  3. Parents shall respond on behalf of their minor children

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01423383

Contact: Michael H. Tirgan, MD (212) 874 4200

United States, New York
Michael H. Tirgan, MD Recruiting
New York, New York, United States, 10023
Contact: Michael H. Tirgan, MD    212-874-4200   
Principal Investigator: Michael H. Tirgan, MD         
Sponsors and Collaborators
Tirgan, Michael H., M.D.
Study Chair: Michael H. Tirgan, MD St. Luke's-Roosevelt Hospital Center

Additional Information:
Responsible Party: Tirgan, Michael H., M.D. Identifier: NCT01423383     History of Changes
Other Study ID Numbers: Tirgan 11-04
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Tirgan, Michael H., M.D.:

Additional relevant MeSH terms:
Collagen Diseases
Connective Tissue Diseases
Pathologic Processes