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

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01423981
• Other study ID #: Tirgan 11-01
• Status: Recruiting
• Phase: N/A
• First received: August 23, 2011
• Last updated: October 3, 2016
• Start date: November 2011
• Est. completion date: June 2031

Study information

• Verified date: October 2016
• Source: Tirgan, Michael H., M.D.
• Contact: Michael H Tirgan, MD
• Phone: (212) 874 4200
• Email: htirgan[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: June 2031
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Keloid

Locations

Country	Name	City	State
United States	Michael H. Tirgan, MD	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tirgan, Michael H., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the prevalence different phenotypes of keloid in participants.	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	No

External Links

•   Official Study Website