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Improving Keloids Using Targeted Ultraviolet-B Irradiation

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT03160053
Collaborator
(none)
2
Enrollment
2
Arms
35.7
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: NB-UVB
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Each participant served as his/hers own control.Each participant served as his/hers own control.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Improving Keloids Using Targeted Ultraviolet-B Irradiation
Actual Study Start Date :
Jun 23, 2015
Actual Primary Completion Date :
Nov 20, 2015
Actual Study Completion Date :
Jun 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • Narrowband UVB

    		•
    No Intervention: Control Group

    Keloids that were randomized to a non treatment group, were not exposed to the NB-UVB light.

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Appearance As Assessed by the Patient and Observer Scar Assessment (POSAS) Scale [16 weeks]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT03160053
    Other Study ID Numbers:
    • IRB00055540
    First Posted:
    May 19, 2017
    Last Update Posted:
    Jun 19, 2018
    Last Verified:
    Jun 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Keloid

    Study Results

    No Results Posted as of Jun 19, 2018