A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Keloid Scars.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03693924|
Recruitment Status : Not yet recruiting
First Posted : October 3, 2018
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment|
|Keloid Scar||Radiation: SRT-100|
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 :||Observational|
|Estimated Enrollment :||100 participants|
|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.|
|Estimated Study Start Date :||November 15, 2018|
|Estimated Primary Completion Date :||February 16, 2019|
|Estimated Study Completion Date :||February 16, 2019|
- Radiation: SRT-100
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693924
|Contact: Isabelle Raymondfirstname.lastname@example.org|
|Principal Investigator:||Brian Berman, M.D.|