KeloidNCT01423981
Web Based Investigation of Natural History of Keloid Disorder, an Online Survey
An observational study of Keloid, run by Tirgan, Michael H., M.D. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with keloid disorder.
Who may be able to join
- 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
Who cannot join
- No one will be excluded from this study as long as the inclusion criteria are met.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michael H. Tirgan, MD
New York, New York, 10023
Michael H Tirgan, MD, 212-874-4200, htirgan@gmail.com
Michael H Tirgan, MD
About this study
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.
- Conditions
- Keloid
- Keywords
- Keloid, Scar, hypertrophic scar, familial keloid
- Medical subject headings
- Keloid, Cicatrix, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with keloid disorder. | All participants have a clinical diagnosis of keloid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tirgan, Michael H., M.D.
- Responsible party
- Sponsor
- Investigators
- Michael H Tirgan, MD, Principal investigator, Keloid Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423981
- Sponsor's protocol ID
- Tirgan 11-01
- Status last verified
- Oct 2016
- First submitted
- 23 Aug 2011
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All data will be shared and published
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web Based Investigation of Natural History of Keloid Disorder, an Online Survey
- ClinicalTrials.gov ID
- NCT01423981
- Acronym / sponsor ID
- Tirgan 11-01
- Conditions
- Keloid
- Keywords
- Keloid, Scar, hypertrophic scar, familial keloid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Tirgan, Michael H., M.D.
- Study start
- Nov 2011
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with keloid disorder. | – | –All participants have a clinical diagnosis of keloid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with keloid disorder.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No one will be excluded from this study as long as the inclusion criteria are met.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the prevalence different phenotypes of keloid in participants.
Time frame: Two years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Official Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data will be shared and published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael H Tirgan, MD principal investigator
Keloid Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keloid, run by Tirgan, Michael H., M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael H Tirgan, MD ((212) 874 4200, htirgan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prevalence different phenotypes of keloid in participants. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.