Back to resultsImproving Keloids Using Targeted Ultraviolet-B Irradiation
Primary Purpose
Keloid
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NB-UVB
Sponsored by
About this trial
This is an interventional treatment trial for Keloid
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Group
Control Group
Arm Description
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.
Keloids that were randomized to a non treatment group, were not exposed to the NB-UVB light.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03160053
Brief Title
Improving Keloids Using Targeted Ultraviolet-B Irradiation
Official Title
Improving Keloids Using Targeted Ultraviolet-B Irradiation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 23, 2015 (Actual)
Primary Completion Date
November 20, 2015 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment of keloids with targeted Ultraviolet-Beta (UVB) radiation will improve the clinical appearance and induration of lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each participant served as his/hers own control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Keloids that were randomized to a non treatment group, were not exposed to the NB-UVB light.
Intervention Type
Device
Intervention Name(s)
NB-UVB
Other Intervention Name(s)
Narrowband UVB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Appearance As Assessed by the Patient and Observer Scar Assessment (POSAS) Scale
Description
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
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Improving Keloids Using Targeted Ultraviolet-B Irradiation
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