Keloid ScarNCT03693924
A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Keloid Scars.
An observational study of Keloid Scar, run by Sensus Healthcare.
Trial summary
Keloid formation in response to skin trauma inflicts about 18 million individuals. A key impediment in successful treatment of keloids is that the predominant treatments, particularly surgical excision and shaving, tend to initiate the regrowth of the keloid at the excision site, and therefore, recurrence rates are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid Scar
- What is being tested?
- SRT-100
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2018to 16 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises patients who were treated with the SRT-100™ for one or more recurrent keloids and who have at least 1 year of follow-up data.
Who may be able to join
- Confirmed diagnosis of keloid(s).
- Treatment with SRT-100™ of one or more keloids.
- At least 1 year since treatment end.
- Required retrospective data is existing and sufficient.
Who cannot join
- Lesions of etiology other than keloids.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Retrospective Registry Study to Evaluate the Long-Term Efficacy and Safety of Superficial Radiation Therapy (SRT) for the Treatment of Recurrent Keloid Scars.
Keloid formation in response to skin trauma inflicts about 18 million individuals. A key impediment in successful treatment of keloids is that the predominant treatments, particularly surgical excision and shaving, tend to initiate the regrowth of the keloid at the excision site, and therefore, recurrence rates are high. There is much evidence to demonstrate that following surgical excision procedures with a course of radiation therapy can significantly reduce recurrence rates to as little as 10% or below. This retrospective study is to evaluate this claim.
Read the detailed description
A keloid is an unsightly non-malignant tumor comprised of an abnormal proliferation of scar tissue that forms at the site of cutaneous injury (e.g. skin trauma such as cuts, abrasions and puncture wounds, burns or surgical incisions). It appears as a raised scar and does not regress and grows beyond the original margins of the scar. Keloids most commonly develop on the earlobes, neck, shoulders, chest, back, upper arms and cheeks. Keloids tends to grow slowly and continue to spread for weeks, months or even years. As a keloid grows, it may cause significant itching, pain, and tenderness upon touch, reduced mobility and emotional distress.
About 18 million people worldwide are genetically prone to form keloids in response to skin trauma, with equal gender distribution and greater susceptibility for darker-skinned individuals and those aged 10 to 30 years.
The greatest obstacle in treating keloids with many available surgical and non-surgical methods is that new keloids typically recur at the site of excision due to the treatment itself. For example, the recurrence rate using surgical excision alone is 45 to 100 percent.
Surgical excision followed by radiotherapy is a helpful treatment option for large and more difficult-to-treat keloids that cannot otherwise be treated by, or have failed, more conservative measures. It is thought that because keloid fibroblasts are sensitive to x-ray irradiation, it may prevent the recurrence of keloids by controlling fibroblast proliferation, arresting the cell cycle, and inducing premature cellular senescence. When surgical keloid excision is followed by Radiation Therapy, recurrence drops dramatically to 10% or below.
The SRT-100™ is a United States Food and Drug Administration (U.S. FDA) approved device for delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) to treat keloids caused by surgery or injury. This retrospective study has been designed to focus on efficacy and safety of the SRT-100™ for the treatment of recurrent keloid scars.
- Conditions
- Keloid Scar
- Being tested
- SRT-100
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRT-100Radiation
The SRT-100™ is a simple painless non-invasive in-office procedure that is approved by the U.S. Food and Drug Administration (U.S. FDA) to treat keloids caused by surgery or injury by delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) that only goes skin deep.
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term recurrence rate
Recurrence rate will be calculated as the percentage of keloids that recurred at the treatment site following treatment completion.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start15 Nov 2018 (estimated)
- Primary completion16 Feb 2019 (estimated)
- Study completion16 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keloid ScarStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sensus Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Berman, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693924
- Sponsor's protocol ID
- SRTS-SRT-002
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Registry Study to Evaluate the Long-Term Efficacy and Safety of Superficial Radiation Therapy (SRT) for the Treatment of Recurrent Keloid Scars.
- ClinicalTrials.gov ID
- NCT03693924
- Acronym / sponsor ID
- SRTS-SRT-002
- Conditions
- Keloid Scar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sensus HealthcareIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2018 (estimated)
- Primary completion
- 16 Feb 2019 (estimated)
- Study completion
- 16 Feb 2019 (estimated)
- First posted
- 3 Oct 2018 (actual)
- 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.
Keloid formation in response to skin trauma inflicts about 18 million individuals. A key impediment in successful treatment of keloids is that the predominant treatments, particularly surgical excision and shaving, tend to initiate the regrowth of the keloid at the excision site, and therefore, recurrence rates are high. There is much evidence to demonstrate that following surgical excision procedures with a course of radiation therapy can significantly reduce recurrence rates to as little as 10% or below. This retrospective study is to evaluate this claim.
Detailed description
A keloid is an unsightly non-malignant tumor comprised of an abnormal proliferation of scar tissue that forms at the site of cutaneous injury (e.g. skin trauma such as cuts, abrasions and puncture wounds, burns or surgical incisions). It appears as a raised scar and does not regress and grows beyond the original margins of the scar. Keloids most commonly develop on the earlobes, neck, shoulders, chest, back, upper arms and cheeks. Keloids tends to grow slowly and continue to spread for weeks, months or even years. As a keloid grows, it may cause significant itching, pain, and tenderness upon touch, reduced mobility and emotional distress.
About 18 million people worldwide are genetically prone to form keloids in response to skin trauma, with equal gender distribution and greater susceptibility for darker-skinned individuals and those aged 10 to 30 years.
The greatest obstacle in treating keloids with many available surgical and non-surgical methods is that new keloids typically recur at the site of excision due to the treatment itself. For example, the recurrence rate using surgical excision alone is 45 to 100 percent.
Surgical excision followed by radiotherapy is a helpful treatment option for large and more difficult-to-treat keloids that cannot otherwise be treated by, or have failed, more conservative measures. It is thought that because keloid fibroblasts are sensitive to x-ray irradiation, it may prevent the recurrence of keloids by controlling fibroblast proliferation, arresting the cell cycle, and inducing premature cellular senescence. When surgical keloid excision is followed by Radiation Therapy, recurrence drops dramatically to 10% or below.
The SRT-100™ is a United States Food and Drug Administration (U.S. FDA) approved device for delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) to treat keloids caused by surgery or injury. This retrospective study has been designed to focus on efficacy and safety of the SRT-100™ for the treatment of recurrent keloid scars.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises patients who were treated with the SRT-100™ for one or more recurrent keloids and who have at least 1 year of follow-up data.
Key inclusion criteria (4 listed)
- Confirmed diagnosis of keloid(s).
- Treatment with SRT-100™ of one or more keloids.
- At least 1 year since treatment end.
- Required retrospective data is existing and sufficient.
Key exclusion criteria (1 listed)
- Lesions of etiology other than keloids.
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 |
|---|---|---|
| SRT-100The SRT-100™ is a simple painless non-invasive in-office procedure that is approved by the U.S. Food and Drug Administration (U.S. FDA) to treat keloids caused by surgery or injury by delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) that only goes skin deep. | Radiation | – |
Primary outcome
Long-term recurrence rate
Time frame: one year
Recurrence rate will be calculated as the percentage of keloids that recurred at the treatment site following treatment completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
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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.
Brian Berman, M.D. principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Keloid Scar, run by Sensus Healthcare.
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: status not confirmed, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Isabelle Raymond (561.922.5808, iraymond@sensushealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term recurrence rate (time frame: one year). 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 3 Oct 2018.