Epidemiology Study of Keloid

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Tirgan, Michael H., M.D.
Sponsor:
Information provided by (Responsible Party):
Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier:
NCT01423383
First received: August 23, 2011
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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
Keloid

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Epidemiology Study of Keloid

Further study details as provided by Tirgan, Michael H., M.D.:

Primary Outcome Measures:
  • Prevalence of various clinical findings will be determined at the end of Survey. [ Time Frame: Two Years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100000
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Random Populations
The aim of this study is to determine the prevalence and incidence of keloid in large populations.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

General population will be sampled randomly

Criteria

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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423383

Contacts
Contact: Michael H. Tirgan, MD (212) 874 4200 htirgan@aol.com

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

Additional Information:
No publications provided

Responsible Party: Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier: NCT01423383     History of Changes
Other Study ID Numbers: Tirgan 11-04
Study First Received: August 23, 2011
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014