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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NB-UVB

Device

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

Primary outcomes

Clinical Appearance As Assessed by the Patient and Observer Scar Assessment (POSAS) Scale

Time frame: 16 weeks

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2018
First posted: May 19, 2017
Registry last updated: Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed