NCT01423383

Brief Summary

Although keloid is a very common condition; there are no statistics as to its true incidence and prevalence, neither in United States, nor elsewhere in the world. This trial intends to capture epidemiological data about this disease in a large population sample.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

8.8 years

First QC Date

August 23, 2011

Last Update Submit

October 17, 2016

Conditions

Keloid

Keywords

Keloid

Outcome Measures

Primary Outcomes (1)

  • Prevalence of various clinical findings will be determined at the end of Survey.

    This will be a prospective online and paper based survey with an estimated 100,000 responders participating in two years. Statistics will be descriptive. The prevalence of various clinical findings will be determined at the end of Survey. Findings will be correlated with the source of the data, online, or paper questionnaire, as well as the locations where the paper questionnaires surveys were placed.

    Two Years

Study Arms (1)

Random Populations

The aim of this study is to determine the prevalence and incidence of keloid in large populations.

Eligibility Criteria

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

General population will be sampled randomly

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael H. Tirgan, MD

New York, New York, 10023, United States

RECRUITING

Related Links

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

    St. Luke's-Roosevelt Hospital Center

    STUDY CHAIR

Central Study Contacts

Michael H. Tirgan, MD

CONTACT

(212) 874 4200htirgan@aol.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 25, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2020

Study Completion

December 1, 2021

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

US(1)