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

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ClinicalTrials.gov Identifier: NCT01423981
Recruitment Status : Recruiting
First Posted : August 26, 2011
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Tirgan, Michael H., M.D.

Brief Summary:
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 or disease
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.


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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Web Based Investigation of Natural History of Keloid Disorder, an Online Survey
Study Start Date : November 2011
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : June 2031

Group/Cohort
Patients with keloid disorder.
All participants have a clinical diagnosis of keloid.



Primary Outcome Measures :
  1. Determine the prevalence different phenotypes of keloid in participants. [ Time Frame: Two years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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. 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01423981


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

Locations
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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@gmail.com   
Principal Investigator: Michael H Tirgan, MD         
Sponsors and Collaborators
Tirgan, Michael H., M.D.
Investigators
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Principal Investigator: Michael H Tirgan, MD Keloid Research Foundation

Additional Information:
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Responsible Party: Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier: NCT01423981     History of Changes
Other Study ID Numbers: Tirgan 11-01
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be shared and published
Keywords provided by Tirgan, Michael H., M.D.:
Keloid
Scar
hypertrophic scar
familial keloid
Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes