Study of Psycho-Social Impact of Keloid | NCT01478243

Studies
Study of Psycho-Social Impact of Keloid

NCT01478243

Sponsor

Tirgan, Michael H., M.D.

Status

Terminated

Last Update Posted

Oct 18, 2016Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Keloid

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of institutional support and IRB related issues.

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Nov 20, 2011

First Submission Date that Met QC Criteria

Nov 22, 2011

First Posted Date

Nov 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2016

Last Update Posted Date

Oct 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical Diagnosis of Keloid
Informed consent
Age above 18 to answer the survey questions
Parents shall respond on behalf of their minor children

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael H Tirgan, MD	Keloid Research Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michael H. Tirgan MD		New York	New York	10024	United States

Condition Browse Module

MeSH Terms

ID	Term
D007627	Keloid

Ancestor Terms

ID	Term
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D002921	Cicatrix

Browse Leaves

Not provided

Browse Branches

Not provided