Radiotherapy for Keloids

NCT04722263 | Recruiting FDA Device

• 1 other identifier: 2020-11620
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Keloid

Outcome Measures

Primary Outcomes (1)

• Treatment-related toxicities

  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 Outcomes (10)

• Cessation of growth or shrinkage of keloids

  Week 0, during treatment (as close to the end of the radiotherapy course as practicable

• Cessation of growth or shrinkage of keloids

  Up to 2 weeks (+/- 1 week) post radiotherapy

• Cessation of growth or shrinkage of keloids

  Up to 6 weeks (+/- 1 week) post radiotherapy

• Cessation of growth or shrinkage of keloids

  Up to 10 weeks (+/- 1 week) post radiotherapy

• Cessation of growth or shrinkage of keloids

  Up to 6 months (+/- 1 month) post radiotherapy

Study Arms (1)

Radiotherapy for patients with nonresectable keloids

EXPERIMENTAL

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

Interventions

Radiotherapy RADIATION

25 Gy in 5 fractions

Also known as: Radiation therapy

Radiotherapy for patients with nonresectable keloids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (12)

• Guix B, Henriquez I, Andres A, Finestres F, Tello JI, Martinez A. Treatment of keloids by high-dose-rate brachytherapy: A seven-year study. Int J Radiat Oncol Biol Phys. 2001 May 1;50(1):167-72. doi: 10.1016/s0360-3016(00)01563-7.

  PMID: 11316560 BACKGROUND

• Mankowski P, Kanevsky J, Tomlinson J, Dyachenko A, Luc M. Optimizing Radiotherapy for Keloids: A Meta-Analysis Systematic Review Comparing Recurrence Rates Between Different Radiation Modalities. Ann Plast Surg. 2017 Apr;78(4):403-411. doi: 10.1097/SAP.0000000000000989.

  PMID: 28177974 BACKGROUND

• Borok TL, Bray M, Sinclair I, Plafker J, LaBirth L, Rollins C. Role of ionizing irradiation for 393 keloids. Int J Radiat Oncol Biol Phys. 1988 Oct;15(4):865-70. doi: 10.1016/0360-3016(88)90119-8.

  PMID: 3182326 BACKGROUND

• Bijlard E, Timman R, Verduijn GM, Niessen FB, Hovius SER, Mureau MAM. Intralesional cryotherapy versus excision with corticosteroid injections or brachytherapy for keloid treatment: Randomised controlled trials. J Plast Reconstr Aesthet Surg. 2018 Jun;71(6):847-856. doi: 10.1016/j.bjps.2018.01.033. Epub 2018 Feb 6.

  PMID: 29426811 BACKGROUND

• Cheraghi N, Cognetta A Jr, Goldberg D. RADIATION THERAPY for the Adjunctive Treatment of Surgically Excised Keloids: A Review. J Clin Aesthet Dermatol. 2017 Aug;10(8):12-15. Epub 2017 Aug 1.

  PMID: 28979658 BACKGROUND

• Renz P, Hasan S, Gresswell S, Hajjar RT, Trombetta M, Fontanesi J. Dose Effect in Adjuvant Radiation Therapy for the Treatment of Resected Keloids. Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):149-154. doi: 10.1016/j.ijrobp.2018.05.027. Epub 2018 May 17.

  PMID: 29970316 BACKGROUND

• Goutos I, Ogawa R. Brachytherapy in the adjuvant management of keloid scars: literature review. Scars Burn Heal. 2017 Nov 10;3:2059513117735483. doi: 10.1177/2059513117735483. eCollection 2017 Jan-Dec.

  PMID: 29799578 BACKGROUND

• Rossi AM, Nehal KS, Lee EH. Radiation-induced Breast Telangiectasias Treated with the Pulsed Dye Laser. J Clin Aesthet Dermatol. 2014 Dec;7(12):34-7.

  PMID: 25584136 BACKGROUND

• Malaker K, Vijayraghavan K, Hodson I, Al Yafi T. Retrospective analysis of treatment of unresectable keloids with primary radiation over 25 years. Clin Oncol (R Coll Radiol). 2004 Jun;16(4):290-8. doi: 10.1016/j.clon.2004.03.005.

  PMID: 15214654 BACKGROUND

• Kim J, Lee SH. Therapeutic results and safety of postoperative radiotherapy for keloid after repeated Cesarean section in immediate postpartum period. Radiat Oncol J. 2012 Jun;30(2):49-52. doi: 10.3857/roj.2012.30.2.49. Epub 2012 Jun 30.

  PMID: 22984682 BACKGROUND

• Lo TC, Seckel BR, Salzman FA, Wright KA. Single-dose electron beam irradiation in treatment and prevention of keloids and hypertrophic scars. Radiother Oncol. 1990 Nov;19(3):267-72. doi: 10.1016/0167-8140(90)90153-n.

  PMID: 2126387 BACKGROUND

• Chren MM, Lasek RJ, Sahay AP, Sands LP. Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg. 2001 Mar-Apr;5(2):105-10. doi: 10.1007/BF02737863. Epub 2001 Mar 21.

  PMID: 11443481 BACKGROUND

MeSH Terms

Conditions

Keloid

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Keyur J Mehta, MD

  Montefiore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Alicea

CONTACT

646-538-9909; daniel.alicea2@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 25, 2021
• Study Start: December 1, 2020
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)