Improving Keloids Using Targeted Ultraviolet-B Irradiation

NCT03160053 | Completed

• 1 other identifier: IRB00055540
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Keloid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Keloids that were randomized to a non treatment group, were not exposed to the NB-UVB light.

Interventions

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.

Also known as: Narrowband UVB

Treatment Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Each participant served as his/hers own control.

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: May 19, 2017
• Study Start: June 23, 2015
• Primary Completion: November 20, 2015
• Study Completion: June 15, 2018
• Last Updated: June 19, 2018

Record last verified: 2018-06