Retrospective Study of Keloid Disorder

Keloid Clinical Trial

Official title:

Retrospective Study of Keloid Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02923596
• Other study ID #: Tirgan 16-01
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2016
• Last updated: October 1, 2016
• Start date: September 2016
• Est. completion date: September 2023

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

Purpose of this retrospective study is to review and analyze the information and data that has been already been generated during the course of routine practice of medicine by the investigators from 2007 up until Sept 1, 2016 from keloid patients who have sought medical care or medical advice for their keloid disorder.

Description:

To retrospectively review and analyze clinical data that has already been collected from keloid patients including photographs taken of keloid lesions during routine practice of medicine by the investigators 1) To better understand natural history of keloid disorder (KD), 2)To determine the ethnic incidence and prevalence of keloid, 3) To determine the rate of familial keloids, 4) To determine response to different treatment modalities, 5) To determine risk factors for development and worsening of keloid lesions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients must have at least one keloid lesion.

• Availability of photographic documentation of keloid lesion(s).

Exclusion Criteria:

• Lack of photographic documentation of keloid lesion(s)

• Lack of demographic data

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Keloid

Intervention

Procedure:
• History of prior Surgery
History of prior Surgery will be reviewed

Radiation:
• History of Radiation Therapy
History of prior radiation therapy will be reviewed

Locations

Country	Name	City	State
United States	Michael H. Tirgan MD	New York	New York
United States	Texas Institute of Dermatology	San Antonio	Texas

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	Rate of development of massive, semi-massive and large Keloids	Keloid Recurrence after surgery is a real-world outcome, one that takes time to develop. Study will intend to explore the long term rate of keloid recurrence after surgery. This rate will be reported as percentage of patients who undergo surgery and end up with developing a massive, semi-massive or large recurrent keloid	1-5 years after surgery	No
Secondary	Rate of poor aesthetic outcome after ear surgery	Surgical intervention often results in loss of ear tissue and poor aesthetic outcome. Although fully expected, the actual rates of this outcome is unknown. Study intends to report the actual rate of disfigurement and poor aesthetic outcome after ear surgery for removal of keloid lesions.	1-5 years after surgery	No