ClinicalTrials.gg
RecruitingNCT01423981Updated Oct 4, 2016

Web Based Investigation of Natural History of Keloid Disorder, an Online Survey

An observational study in Keloid, sponsored by Tirgan, Michael H., M.D.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-04.

Sponsored by Tirgan, Michael H., M.D. · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This will be a web based study, whereby patients will have to read and acknowledge the consent form online. Once patients agree and acknowledge the terms of the consent form, they will gain access to the questionnaire pages.

For those who are under age of 18, a parent or a legal guardian must sign the consent form and answer the online questions on behalf of the patient.

02

Conditions studied

  • Keloid

Keywords

  • Keloid
  • Scar
  • hypertrophic scar
  • familial keloid
03

In context

Keloid

138 studies on the registry are indexed under Keloid; 26 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 100 across 23 observational studies indexed under Keloid.

Browse Keloid studies →

Lead sponsor

Tirgan, Michael H., M.D. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with keloid disorder.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No one will be excluded from this study as long as the inclusion criteria are met.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
10,000 participants (estimated)

Groups and cohorts

  • Patients with keloid disorder.

    All participants have a clinical diagnosis of keloid.

06

What researchers measure

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.

    Time frame: Two years

07

Study locations

1 of 1 sites recruiting
  • Michael H. Tirgan, MD
    New York, New York 10023, United States
    Recruiting
    • Michael H Tirgan, MD · Contacthtirgan@gmail.com · 212-874-4200
    • Michael H Tirgan, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — All data will be shared and published

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2011, a primary completion of Dec 2030 and a completion of Jun 2031. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2011
First posted
Aug 26, 2011
Start
Nov 2011
Primary completionEst.
Dec 2030
CompletionEst.
Jun 2031
Last update
Oct 4, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01423981
Lead sponsor
Tirgan, Michael H., M.D.
Responsible party
Sponsor
First posted
Aug 26, 2011
Start date
Nov 2011
Primary completion
Dec 2030 (estimated)
Completion
Jun 2031 (estimated)
Last update
Oct 4, 2016

Study contacts

Michael H Tirgan, MD
Contact
htirgan@gmail.com
(212) 874 4200
Michael H Tirgan, MD
principal investigator · Keloid Research Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion