Improving Keloids Using Targeted Ultraviolet-B Irradiation

Keloid Clinical Trial

Official title:

Improving Keloids Using Targeted Ultraviolet-B Irradiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160053
• Other study ID #: IRB00055540
• Status: Completed
• Phase: N/A
• Start date: June 23, 2015
• Est. completion date: June 15, 2018

Study information

• Verified date: June 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 15, 2018
• Est. primary completion date: November 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keloid

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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