- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693924
A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Keloid Scars.
A Retrospective Registry Study to Evaluate the Long-Term Efficacy and Safety of Superficial Radiation Therapy (SRT) for the Treatment of Recurrent Keloid Scars.
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Isabelle Raymond
- Phone Number: 561.922.5808
- Email: iraymond@sensushealthcare.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria
- Lesions of etiology other than keloids.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian Berman, M.D.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRTS-SRT-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keloid Scar
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