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Web Based Investigation of Natural History of Keloid Disorder, an Online Survey

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Tirgan, Michael H., M.D.
Information provided by (Responsible Party):
Tirgan, Michael H., M.D. Identifier:
First received: August 23, 2011
Last updated: October 3, 2016
Last verified: October 2016
This trial intends to gather very basic clinical information about keloid, its patterns of presentation, family history, ethnic background and correlation with the type of keloid, as well as prior treatment results that patients have had received.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Web Based Investigation of Natural History of Keloid Disorder, an Online Survey

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

Primary Outcome Measures:
  • Determine the prevalence different phenotypes of keloid in participants. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Prevalence of different phenotypes of keloid will be measured in the study population and reported. Prevalence of familial keloid in the study population will also be determined and reported. Data will be analyzed to determine the distribution of keloid among different ethic groups. Data will be analyzed to report the percentage of patients who have had one or more treatments and the percentage of patients who have had successful treatments.

Estimated Enrollment: 10000
Study Start Date: November 2011
Estimated Study Completion Date: June 2031
Estimated Primary Completion Date: December 2030 (Final data collection date for primary outcome measure)
Patients with keloid disorder.
All participants have a clinical diagnosis of keloid.

Detailed Description:

This will be a web based study, whereby patients will have to read and acknowledge the consent form online. Once patients agree and acknowledge the terms of the consent form, they will gain access to the questionnaire pages.

For those who are under age of 18, a parent or a legal guardian must sign the consent form and answer the online questions on behalf of the patient.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with keloid disorder.

Inclusion Criteria:

  1. Patients must have clinically confirmed diagnosis of keloid
  2. Adults, age over 18
  3. Parent or legal guardian may participate if patient is under the age of 18
  4. Able and willing to complete a web based survey

Exclusion Criteria:

  • No one will be excluded from this study as long as the inclusion criteria are met.
  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 identifier: NCT01423981

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.
Principal Investigator: Michael H Tirgan, MD Keloid Research Foundation
  More Information

Additional Information:
Responsible Party: Tirgan, Michael H., M.D. Identifier: NCT01423981     History of Changes
Other Study ID Numbers: Tirgan 11-01 
Study First Received: August 23, 2011
Last Updated: October 3, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: All data will be shared and published

Keywords provided by Tirgan, Michael H., M.D.:
hypertrophic scar
familial keloid

Additional relevant MeSH terms:
Collagen Diseases
Connective Tissue Diseases
Pathologic Processes processed this record on October 21, 2016