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Web Based Investigation of Natural History of Keloid; An Online Survey of Patients With Keloid

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier:
NCT01423981
First received: August 23, 2011
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

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.


Condition
Keloid

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Web Based Investigation of Natural History of Keloid; An Online Survey of Patients With Keloid

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 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with keloid disorder.

Criteria

Inclusion Criteria:

  1. Patients must have clinically confirmed diagnosis of keloid
  2. All Ages
  3. Signed consent form ( by parent or legal guardian 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 trial 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 ClinicalTrials.gov identifier: NCT01423981

Locations
United States, New York
Michael H. Tirgan, MD
New York, New York, United States, 10023
Sponsors and Collaborators
Tirgan, Michael H., M.D.
Investigators
Principal Investigator: 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: NCT01423981     History of Changes
Other Study ID Numbers: Tirgan 11-01
Study First Received: August 23, 2011
Last Updated: November 14, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014