Improving Keloids Using Targeted Ultraviolet-B Irradiation

Treatment of keloids with targeted Ultraviolet-Beta (UVB) radiation will improve the clinical appearance and induration of lesions.

Study Overview

• Status: Completed
• Conditions: Keloid
• Intervention / Treatment: Device: NB-UVB

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

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:

• Participants must be 18 years old or over
• Participants must have a diagnosis of keloid
• No treatment with topical or intralesional steroids for 1 month prior to study

Exclusion Criteria:

• Patients who are unable to provide informed consent
• A history of photosensitivity, lupus erythematosus, porphyria or current use of a known photosensitizing drug
• Unwillingness to stop with topical or intralesional steroids for 1 month prior to study
• A history of malignant melanoma
• A history of radiation therapy to area of interest
• Subjects who self-report that they are pregnant or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group; Keloids that were randomized to the treatment group, were exposed to Narrowband-UVB (NB-UVB). Targeted UVB will be delivered to the keloid for up to 16 weeks using the Lumera UVB light phototherapy device (Daavlin, Bryan Ohio, USA).The affected skin will be irradiated using a hand-held fiber optic cable with an adjustable aperture.	Device: NB-UVB; NB-UVB has an emission spectrum in the ultraviolet B range of 290-320 nm. The system consists of a light source, a spot handpiece, and a light guide that connects the handpiece to the light source. The light source has a Start/Stop switch for light beam activation. Activation can also be controlled remotely with a foot switch. The light source has a timer and an output level control to adjust the intensity of the ultraviolet light. This will be calibrated using a manufacturer-provided UV meter prior to every treatment to ensure accurate doses of ultraviolet light.; Other Names: Narrowband UVB
NO_INTERVENTION: Control Group; Keloids that were randomized to a non treatment group, were not exposed to the NB-UVB light.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Appearance As Assessed by the Patient and Observer Scar Assessment (POSAS) Scale	Investigators will evaluate the pre- and post-study clinical photographs of all participants. The grading investigator will grade the degree of improvement using the POSAS scale to measure the clinical appearance of the keloids	16 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2015
• Primary Completion (ACTUAL): November 20, 2015
• Study Completion (ACTUAL): June 15, 2018

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (ACTUAL): May 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: June 1, 2018

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: IRB00055540

Drug and device information, study documents

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