Study of Psycho-Social Impact of Keloid

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier:
NCT01478243
First received: November 20, 2011
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

Despite their benign nature, keloids may constitute a severe aesthetic, and in some cases, functional problem which translates to various repercussions on person's quality of life, including much stress and insecurities.

Keloids are mostly observed between the ages of 10 and 30. Although keloid is a common condition and the investigators can make assumptions about those living with keloids, the investigators do not know the actual impact of the illness on the overall performance of patients' and how this disease, day to day, is impacting their lives. The investigators are conducting this study, aimed to investigate the psychosocial impact of keloid on daily life. Information is collected anonymously. You must be 18 years of age or older to take this survey. Parents can respond on behalf of their children who are not 18 years of age yet. The online survey will take 20-30 minutes to complete.


Condition
Keloid

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Study of Psycho-Social Impact of Keloid

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

Estimated Enrollment: 1000
Study Start Date: September 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

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

All patients with clinical diagnosis of Keloid are invited to particiapate in this study.

Criteria

Inclusion Criteria:

  1. Clinical Diagnosis of Keloid
  2. Informed consent
  3. Age above 18 to answer the survey questions
  4. Parents shall respond on behalf of their minor children
  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: NCT01478243

Locations
United States, New York
Michael H. Tirgan MD
New York, New York, United States, 10024
Sponsors and Collaborators
Tirgan, Michael H., M.D.
Investigators
Principal Investigator: Michael H Tirgan, MD Keloid Research Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier: NCT01478243     History of Changes
Other Study ID Numbers: 11-07
Study First Received: November 20, 2011
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tirgan, Michael H., M.D.:
Keloid

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

ClinicalTrials.gov processed this record on August 21, 2014