NCT01478243

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

November 20, 2011

Last Update Submit

October 17, 2016

Conditions

Keloid

Keywords

Keloid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael H. Tirgan MD

New York, New York, 10024, United States

Location

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael H Tirgan, MD

    Keloid Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2011

First Posted

November 23, 2011

Study Start

September 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

US(1)