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

October 3, 2016 updated by: Tirgan, Michael H., M.D.
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 Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10023
        • Recruiting
        • Michael H. Tirgan, MD
        • Principal Investigator:
          • Michael H Tirgan, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with keloid disorder.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tirgan, Michael H., M.D.

Investigators

  • Principal Investigator: Michael H Tirgan, MD, Keloid Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

December 1, 2030

Study Completion (Anticipated)

June 1, 2031

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tirgan 11-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be shared and published

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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