Epidemiology Study of Keloid

This study is currently recruiting participants.

Verified September 2011 by Tirgan, Michael H., M.D.

First Received on August 23, 2011. Last Updated on September 16, 2011 History of Changes

Sponsor:	Tirgan, Michael H., M.D.
Information provided by (Responsible Party):	Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier:	NCT01423383

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 2014
Estimated Primary Completion Date:	June 2014 (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:

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

Exclusion Criteria:

None

Contacts and Locations

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:

This is the official website of this study. This link exits the ClinicalTrials.gov site

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:	September 16, 2011
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 May 23, 2012