KeloidNCT01478243
Study of Psycho-Social Impact of Keloid
An observational study of Keloid, run by Tirgan, Michael H., M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Keloid
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with clinical diagnosis of Keloid are invited to particiapate in this study.
Who may be able to join
- Clinical Diagnosis of Keloid
- Informed consent
- Age above 18 to answer the survey questions
- Parents shall respond on behalf of their minor children
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Keloid
- Keywords
- Keloid
- Medical subject headings
- Keloid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startSep 2012
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Lack of institutional support and IRB related issues.
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
- 1,000 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
- NCT01478243
- Sponsor's protocol ID
- 11-07
- Status last verified
- Oct 2016
- First submitted
- 20 Nov 2011
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Psycho-Social Impact of Keloid
- ClinicalTrials.gov ID
- NCT01478243
- Acronym / sponsor ID
- 11-07
- Conditions
- Keloid
- Keywords
- Keloid
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of institutional support and IRB related issues.
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tirgan, Michael H., M.D.
- Study start
- Sep 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 23 Nov 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with clinical diagnosis of Keloid are invited to particiapate in this study.
Key inclusion criteria (4 listed)
- Clinical Diagnosis of Keloid
- Informed consent
- Age above 18 to answer the survey questions
- Parents shall respond on behalf of their minor children
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lack of institutional support and IRB related issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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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. This study is not recruiting at the moment.
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 0 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: stopped early, as of the sponsor's last update on 18 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?
The study was stopped early (reason given: Lack of institutional support and IRB related issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 18 Oct 2016.