Improving Keloids Using Targeted Ultraviolet-B Irradiation

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

Official Title
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Improving Keloids Using Targeted Ultraviolet-B Irradiation

Conditions
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Keloid

Intervention / Treatment
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* Device: NB-UVB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each participant served as his/hers own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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<br>* 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.<br>* Other names: Narrowband UVB;|
| No Intervention: Control Group<br>Keloids that were randomized to a non treatment group, were not exposed to the NB-UVB light. | |

What is the study measuring?
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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 |