Primary Radiotherapy for the Treatment of Keloids: A Pilot Study

This will be a single-institution pilot study to evaluate the safety and efficacy of radiation therapy (RT) for the treatment of unresected keloids. The primary endpoint will be toxicity within 10 weeks of follow-up. Secondary endpoints will include cessation of growth or shrinkage of keloids, symptomatic response, and impact on quality of life.

Study Overview

• Status: Recruiting
• Conditions: Safety and Efficacy of Radiation Therapy for the Treatment of Keloids
• Intervention / Treatment: Other: Radiation therapy of unresected keloids

Detailed Description

Risks of radiation therapy include acute and later toxicities. Acute toxicities of radiation therapy include radiation dermatitis (skin pain, itching, erythema, desquamation). Late toxicities include skin fibrosis, ulceration, telangiectasia, altered skin pigmentation, delayed wound healing for potential future wounds in the irradiated field, and radiation induced malignancy in the irradiated field (lifetime risk estimated to be 1% or less) Additionally, efficacy of the treatment is not known and there is a risk that the keloid will continue to grow immediately or in the future resulting in treatment providing patients with no benefit but with the included aforementioned acute and late toxicities of the RT.

The potential benefits of this study include prevention of keloid progression, keloid improvement or resolution with symptomatic relief and cosmetic. This therapeutic option uniquely provides these benefits for patients who are otherwise lacking efficacious treatment options for their keloids. Previous published studies of similar regimens suggest that rates of symptom control and/or stable to reduced keloid size of 75% or higher may be achieved with our regimen.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jonathan Klein, MD; Phone Number: 718-920-2750; Email: joklein@montefiore.org
• Study Contact Backup: Name: Madhur Garg, MD; Phone Number: 718-920-4361; Email: mgarg@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Albert Einstein College of Medicine
      • Principal Investigator: Madhur K. Garg
      • Contact: Madhur K. Garg; Phone Number: 718-920-4361; Email: mgarg@montefiore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 decline 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiation therapy group; Single-institution pilot study to evaluate the safety and efficacy of radiation therapy (RT) for the treatment of unresected keloids. The primary endpoint will be toxicity within 10 weeks of follow-up. Secondary endpoints will include cessation of growth or shrinkage of keloids, symptomatic response, and impact on quality of life.	Other: Radiation therapy of unresected keloids; radiation therapy (RT) for the treatment of unresected keloids. The primary endpoint will be toxicity within 10 weeks of follow-up. Secondary endpoints will include cessation of growth or shrinkage of keloids, symptomatic response, and impact on quality of life.; Other Names: therapy of unresected keloids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity of the radiation	Number of participants with treatment-related adverse events	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of keloids	size of keloids	1 year

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Keloid
• Other Study ID Numbers: 2020-11620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No