Recruiting

Superficial Radiation Therapy

Sponsor:

Sensus Healthcare

Code:

NCT04184011

Conditions

Keloid Scar

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

SRT-100™

Study Details

Brief 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 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.

Conditions

Keloid Scar

Study ID

NCT04184011

Start date

Aug 15, 2019

Status verified date

Nov, 2019

Completion date

Aug 16, 2020

Anticipated

Primary completion date

Aug 16, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

SRT for keloid scars

Individuals who are voluntarily scheduled to be treated at one of the participating study sites with SRT (SRT-100™, SRT-Vision™ or SRT-100+™) for the treatment of one or more recurrent keloids.

Interventions

SRT-100™

SRT delivers a precise, calibrated dose of radiotherapy following surgical excision for large and more difficult-to-treat keloids that cannot otherwise be treated by or have failed more conservative measures.

Primary outcome measure

  • Incidence of keloid recurrence rates. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Isabelle Raymond

561-922-5808iraymond@sensushealthcare.com

Locations

Dermatology and Dermatological Surgery

Recruiting

Boynton Beach, Florida, United States, 33437

Contacts

William I Roth, MD

561-731-4900info@williamrothMD.com

More Information

Sponsor

Sensus Healthcare

Last update posted

Dec 3, 2019

Last verified

Nov, 2019

Keywords

  • Superficial Radiation Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sensus Healthcare on 2019-12-03.