NCT01423981

Brief Summary

This trial intends to gather very basic clinical information about keloid, its patterns of presentation, family history, ethnic background and correlation with the type of keloid, as well as prior treatment results that patients have had received.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
61mo left

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress74%
Nov 2011Jun 2031

First Submitted

Initial submission to the registry

August 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
19.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

19.1 years

First QC Date

August 23, 2011

Last Update Submit

October 3, 2016

Conditions

Keywords

KeloidScarhypertrophic scarfamilial keloid

Outcome Measures

Primary Outcomes (1)

  • Determine the prevalence different phenotypes of keloid in participants.

    Prevalence of different phenotypes of keloid will be measured in the study population and reported. Prevalence of familial keloid in the study population will also be determined and reported. Data will be analyzed to determine the distribution of keloid among different ethic groups. Data will be analyzed to report the percentage of patients who have had one or more treatments and the percentage of patients who have had successful treatments.

    Two years

Study Arms (1)

Patients with keloid disorder.

All participants have a clinical diagnosis of keloid.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with keloid disorder.

You may qualify if:

  • Patients must have clinically confirmed diagnosis of keloid
  • Adults, age over 18
  • Parent or legal guardian may participate if patient is under the age of 18
  • Able and willing to complete a web based survey

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

KeloidCicatrixCicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael H Tirgan, MD

    Keloid Research Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael H Tirgan, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 26, 2011

Study Start

November 1, 2011

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

June 1, 2031

Last Updated

October 4, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

All data will be shared and published

Locations