KeloidNCT02923596
Retrospective Study of Keloid Disorder
An observational study of Keloid, run by Tirgan, Michael H., M.D. at 2 sites in United States.
Trial summary
Purpose of this retrospective study is to review and analyze the information and data that has been already been generated during the course of routine practice of medicine by the investigators from 2007 up until Sept 1, 2016 from keloid patients who have sought medical care or medical advice for their keloid disorder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Keloid
- What is being tested?
- History of prior Surgery and History of Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Sep 2023
- 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 a diagnosis of keloid
Who may be able to join
- All patients must have at least one keloid lesion.
- Availability of photographic documentation of keloid lesion(s).
Who cannot join
- Lack of photographic documentation of keloid lesion(s)
- Lack of demographic data
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Michael H. Tirgan MD
New York, New York, 10024
Michael H Tirgan, MD, 212-874-4200, htirgan@aol.com
Michael H Tirgan, MD
- Recruiting
Texas Institute of Dermatology
San Antonio, Texas, 78257
Reza Ghohestani, MD, PhD, 210-698-6777, ghohestani@gmail.com
Reza Ghohestani, MD, PhD
About this study
Purpose of this retrospective study is to review and analyze the information and data that has been already been generated during the course of routine practice of medicine by the investigators from 2007 up until Sept 1, 2016 from keloid patients who have sought medical care or medical advice for their keloid disorder.
Read the detailed description
To retrospectively review and analyze clinical data that has already been collected from keloid patients including photographs taken of keloid lesions during routine practice of medicine by the investigators 1) To better understand natural history of keloid disorder (KD), 2)To determine the ethnic incidence and prevalence of keloid, 3) To determine the rate of familial keloids, 4) To determine response to different treatment modalities, 5) To determine risk factors for development and worsening of keloid lesions.
- Conditions
- Keloid
- Being tested
- History of prior Surgery, History of Radiation Therapy
- Keywords
- Keloid
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
History of prior SurgeryProcedure or surgery
Also called Surgery
History of prior Surgery will be reviewed
History of Radiation TherapyRadiation
Also called Radiation Therapy
History of prior radiation therapy will be reviewed
| Study group | Role | What they receive |
|---|---|---|
| Patients with Ear Keloids | Records of Patients with Ear Keloids will be reviewed. Data and photographs will be analysed. Receives: Procedure: History of prior Surgery; Radiation: History of Radiation Therapy | |
| Patients with Neck Keloids | Records of Patients with Neck area Keloids will be reviewed. Data and photographs will be analysed. Receives: Procedure: History of prior Surgery; Radiation: History of Radiation Therapy | |
| Patients with Scalp Keloids | Records of Patients with Scalp Keloids will be reviewed. Data and photographs will be analysed. Receives: Procedure: History of prior Surgery; Radiation: History of Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of development of massive, semi-massive and large Keloids
Keloid Recurrence after surgery is a real-world outcome, one that takes time to develop. Study will intend to explore the long term rate of keloid recurrence after surgery. This rate will be reported as percentage of patients who undergo surgery and end up with developing a massive, semi-massive or large recurrent keloid
Measured: 1-5 years after surgery
Secondary outcomes (1)
Rate of poor aesthetic outcome after ear surgery
Surgical intervention often results in loss of ear tissue and poor aesthetic outcome. Although fully expected, the actual rates of this outcome is unknown. Study intends to report the actual rate of disfigurement and poor aesthetic outcome after ear surgery for removal of keloid lesions.
Measured: 1-5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tirgan, Michael H., M.D.
- Responsible party
- Sponsor
- Investigators
- Michael H Tirgan, MD, Study chair, Keloid Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923596
- Sponsor's protocol ID
- Tirgan 16-01
- Status last verified
- Oct 2016
- First submitted
- 12 Sep 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
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
- Retrospective Study of Keloid Disorder
- ClinicalTrials.gov ID
- NCT02923596
- Acronym / sponsor ID
- Tirgan 16-01
- Conditions
- Keloid
- Keywords
- Keloid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Tirgan, Michael H., M.D.
- Study start
- Sep 2016
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 4 Oct 2016 (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.
Purpose of this retrospective study is to review and analyze the information and data that has been already been generated during the course of routine practice of medicine by the investigators from 2007 up until Sept 1, 2016 from keloid patients who have sought medical care or medical advice for their keloid disorder.
Detailed description
To retrospectively review and analyze clinical data that has already been collected from keloid patients including photographs taken of keloid lesions during routine practice of medicine by the investigators 1) To better understand natural history of keloid disorder (KD), 2)To determine the ethnic incidence and prevalence of keloid, 3) To determine the rate of familial keloids, 4) To determine response to different treatment modalities, 5) To determine risk factors for development and worsening of keloid lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Ear Keloids | – | Procedure: History of prior Surgery, Radiation: History of Radiation TherapyRecords of Patients with Ear Keloids will be reviewed. Data and photographs will be analysed. |
| Patients with Neck Keloids | – | Procedure: History of prior Surgery, Radiation: History of Radiation TherapyRecords of Patients with Neck area Keloids will be reviewed. Data and photographs will be analysed. |
| Patients with Scalp Keloids | – | Procedure: History of prior Surgery, Radiation: History of Radiation TherapyRecords of Patients with Scalp Keloids will be reviewed. Data and photographs will be analysed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a diagnosis of keloid
Key inclusion criteria (2 listed)
- All patients must have at least one keloid lesion.
- Availability of photographic documentation of keloid lesion(s).
Key exclusion criteria (2 listed)
- Lack of photographic documentation of keloid lesion(s)
- Lack of demographic data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| History of prior SurgeryAlso: SurgeryHistory of prior Surgery will be reviewed | Procedure or surgery | Patients with Ear Keloids, Patients with Neck Keloids, Patients with Scalp Keloids |
| History of Radiation TherapyAlso: Radiation TherapyHistory of prior radiation therapy will be reviewed | Radiation | Patients with Ear Keloids, Patients with Neck Keloids, Patients with Scalp Keloids |
Primary outcome
Rate of development of massive, semi-massive and large Keloids
Time frame: 1-5 years after surgery
Keloid Recurrence after surgery is a real-world outcome, one that takes time to develop. Study will intend to explore the long term rate of keloid recurrence after surgery. This rate will be reported as percentage of patients who undergo surgery and end up with developing a massive, semi-massive or large recurrent keloid
1 secondary outcome
Rate of poor aesthetic outcome after ear surgery
Time frame: 1-5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: Yes
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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 study chair
Keloid Research Foundation
2 sites 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 2 sites 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 2 inclusion and 2 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: status not confirmed, 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 2 sites 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?
Results are not available in the source record.
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?
Rate of development of massive, semi-massive and large Keloids (time frame: 1-5 years after surgery). 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.