Radiotherapy for Keloids

January 27, 2026 updated by: Montefiore Medical Center

Primary Radiotherapy for the Treatment of Keloids: A Pilot Study

The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a single-institution pilot study to evaluate the safety and efficacy of radiation therapy (RT) for the treatment of unresected keloids.

Primary Objective:

Evaluate feasibility and safety of radiation therapy only for the treatment of unresected keloids.

Secondary Objectives:

  • To evaluate toxicity of RT for the treatment of unresected keloids.
  • To evaluate response of keloids, either stability or decrease in size, after primary RT.
  • To evaluate symptomatic response of unresected keloids to primary RT.
  • To assess the effect on quality of life of primary RT for unresected keloids

After review of the literature on the use of RT for the treatment of keloids, both resected and unresected, as well as input of expert opinion and clinical experience by the study's radiation oncologists, the RT prescription dose for this study was selected to be 15 Gy, which will be divided into 5 Gy fractions delivered daily over on 3 consecutive days.

Patients will receive RT using external beam radiotherapy (EBRT), delivered via either electrons or megavoltage photons, or brachytherapy; RT modality will be based on the judgment of the treating radiation oncologist. The investigator team estimates that 15-20 patients will be able to be recruited. In successive intervals of enrollment and treatment of 5 patients (i.e., after 5, 10, and 15 patients have been enrolled), the study team will meet and perform interim analysis to evaluate the safety and efficacy of treatment. Investigators will discuss rates of toxicity and symptom management observed up to that point and determine if the study dose or protocol needs to be altered.

Patients will be evaluated frequently for treatment-related toxicities using CTCAE v5.0 up to 1 year after completion of RT. Any adverse event will be considered by the study investigators to evaluate the safety of the protocol and to determine whether changes to the dosing regimen are required.

Once patients have been identified as having a keloid that will not be surgically resected they will be referred to the radiation oncology department at Montefiore Medical Center. Patients will be seen by a treating radiation oncologist and treatment with the assigned dose schedule will be planned using either EBRT with electrons or high dose-rate radiotherapy (HDR) brachytherapy as deemed appropriate by the treating radiation oncologist.

Amendment for increased dose (3/2023): The treatment dose of 25 Gy in 5 fractions will be prescribed to the 90% isodose line. Treatments will be given on consecutive days (Monday through Friday not including weekends), and all efforts will be made to not introduce a weekend break if at between treatment fractions.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinically diagnosed keloid
  • Surgical excision of keloid is either contraindicated or patient has declined treatment with surgical excision (Note: patients with keloids that recurred after previous resection are eligible, as long as the current keloid is either unresectable or patient has declined resection)
  • Age ≥ 18
  • Study specific informed consent provided

Exclusion Criteria:

  • Prior RT to the area of interest that would result in overlap of radiation therapy fields
  • Females of child bearing age without a negative serum pregnancy test prior to initiation of RT or unwilling to use contraception prior to and during the radiation course
  • Keloids in areas where radiation therapy introduces unacceptable high risk of toxicity as determined by the treating radiation oncologist
  • Uncontrolled intercurrent illness (e.g. symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or psychiatric situation) that would limit compliance with study requirements as judged by the treatment physicians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy for patients with nonresectable keloids
Patients will be seen by a treating radiation oncologist and treatment with the assigned dose schedule will be planned using either EBRT with electrons or high dose-rate radiotherapy (HDR) brachytherapy as deemed appropriate by the treating radiation oncologist. The treatment dose of 25 Gy in 5 fractions will be prescribed to the 90% isodose line.
Radiation: Radiotherapy
25 Gy in 5 fractions
Other Names:
  • Radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related toxicities
Time Frame: Up to 1 year (+/- 1 month) post radiotherapy
The number of patients with treatment related toxicities will be determined by the incidence of grade 2 or higher skin-related adverse events based on CTCAE V5.0 criteria during prescheduled study visits. The number of patients with treatment related toxicities will be reported in aggregate for all visits.
Up to 1 year (+/- 1 month) post radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cessation of growth or shrinkage of keloids
Time Frame: Week 0, during treatment (as close to the end of the radiotherapy course as practicable
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Week 0, during treatment (as close to the end of the radiotherapy course as practicable
Cessation of growth or shrinkage of keloids
Time Frame: Up to 2 weeks (+/- 1 week) post radiotherapy
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Up to 2 weeks (+/- 1 week) post radiotherapy
Cessation of growth or shrinkage of keloids
Time Frame: Up to 6 weeks (+/- 1 week) post radiotherapy
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Up to 6 weeks (+/- 1 week) post radiotherapy
Cessation of growth or shrinkage of keloids
Time Frame: Up to 10 weeks (+/- 1 week) post radiotherapy
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Up to 10 weeks (+/- 1 week) post radiotherapy
Cessation of growth or shrinkage of keloids
Time Frame: Up to 6 months (+/- 1 month) post radiotherapy
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Up to 6 months (+/- 1 month) post radiotherapy
Cessation of growth or shrinkage of keloids
Time Frame: Up to 1 year (+/- 1 month) post radiotherapy
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Up to 1 year (+/- 1 month) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Time Frame: During treatment. Assessed as close to the end of the radiotherapy course as practicable, up to ~1 week
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
During treatment. Assessed as close to the end of the radiotherapy course as practicable, up to ~1 week
Quality of Life as determined by SKINDEX-16 questionnaire
Time Frame: Up to 10 weeks (+/- 1 week) post radiotherapy
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Up to 10 weeks (+/- 1 week) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Time Frame: Up to 6 months (+/- 1 month) post radiotherapy
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Up to 6 months (+/- 1 month) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Time Frame: Up to 1 year (+/- 1 month) post radiotherapy
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Up to 1 year (+/- 1 month) post radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Keyur J Mehta, MD, Montefiore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-11620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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