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Improving Keloids Using Targeted Ultraviolet-B Irradiation

Primary Purpose

Keloid

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NB-UVB
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 7, 2017
    Last Updated
    June 15, 2018
    Sponsor
    Johns Hopkins University
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    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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