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Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT04853433
Study type Interventional
Source Albert Einstein College of Medicine
Contact Jonathan Klein, MD
Phone 718-920-2750
Email [email protected]
Status Recruiting
Phase Early Phase 1
Start date December 1, 2020
Completion date December 1, 2024