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Retrospective Study of Keloid Disorder

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ClinicalTrials.gov Identifier: NCT02923596
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Tirgan, Michael H., M.D.

Brief 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.

Condition or disease Intervention/treatment
Keloid Procedure: History of prior Surgery Radiation: History of Radiation Therapy

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of Keloid Disorder
Study Start Date : September 2016
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Group/Cohort Intervention/treatment
Patients with Ear Keloids
Records of Patients with Ear Keloids will be reviewed. Data and photographs will be analysed.
Procedure: History of prior Surgery
History of prior Surgery will be reviewed
Other Name: Surgery

Radiation: History of Radiation Therapy
History of prior radiation therapy will be reviewed
Other Name: Radiation Therapy

Patients with Neck Keloids
Records of Patients with Neck area Keloids will be reviewed. Data and photographs will be analysed.
Procedure: History of prior Surgery
History of prior Surgery will be reviewed
Other Name: Surgery

Radiation: History of Radiation Therapy
History of prior radiation therapy will be reviewed
Other Name: Radiation Therapy

Patients with Scalp Keloids
Records of Patients with Scalp Keloids will be reviewed. Data and photographs will be analysed.
Procedure: History of prior Surgery
History of prior Surgery will be reviewed
Other Name: Surgery

Radiation: History of Radiation Therapy
History of prior radiation therapy will be reviewed
Other Name: Radiation Therapy




Primary Outcome Measures :
  1. Rate of development of massive, semi-massive and large Keloids [ Time Frame: 1-5 years after surgery ]
    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


Secondary Outcome Measures :
  1. Rate of poor aesthetic outcome after ear surgery [ Time Frame: 1-5 years after 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with a diagnosis of keloid
Criteria

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

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): NCT02923596


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, 10024
Contact: Michael H Tirgan, MD    212-874-4200    htirgan@aol.com   
Principal Investigator: Michael H Tirgan, MD         
United States, Texas
Texas Institute of Dermatology Recruiting
San Antonio, Texas, United States, 78257
Contact: Reza Ghohestani, MD, PhD    210-698-6777    ghohestani@gmail.com   
Principal Investigator: Reza Ghohestani, MD, PhD         
Sponsors and Collaborators
Tirgan, Michael H., M.D.
Investigators
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Study Chair: Michael H Tirgan, MD Keloid Research Foundation

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Responsible Party: Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier: NCT02923596    
Other Study ID Numbers: Tirgan 16-01
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Tirgan, Michael H., M.D.:
Keloid
Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes