Improving Keloids Using Targeted Ultraviolet-B Irradiation
NCT ID: NCT03160053
Last Updated: 2018-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2 participants
INTERVENTIONAL
2015-06-23
2018-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Control Group
Keloids that were randomized to a non treatment group, were not exposed to the NB-UVB light.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have a diagnosis of keloid
* No treatment with topical or intralesional steroids for 1 month prior to study
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Other Identifiers
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IRB00055540
Identifier Type: -
Identifier Source: org_study_id
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