Boynton Beach,
Florida
33437
Purpose:
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 prospective
study is to evaluate this claim.
Study summary:
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 prospective study has been designed to focus on recurrence
rates and associated treatment variables of the SRT-100™ for the treatment of recurrent
keloid scars.
Criteria:
Inclusion Criteria:
- Confirmed diagnosis of keloid(s)
- Independently scheduled for treatment with SRT-100™, SRT-Vision™ or SRT-100+™ for one
or more keloids
- Subject voluntary provides written consent to be in the study
Exclusion Criteria:
- Lesions of etiology other than keloids
- Any factor(s) that in the professional opinion of the investigator warrants the
individual unsuitable for study participation