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Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

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ClinicalTrials.gov Identifier: NCT03270241
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE August 28, 2017
First Posted Date  ICMJE September 1, 2017
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
Molecular changes from NB-UVB therapy [ Time Frame: 2 years ]
The investigators are assessing the histological and molecular changes of normal and Vitiligo-lesion skin from NB-UVB therapy. The molecular markers (in microgram/ mL) include, but not limited to, KIT receptor, stem cell factor (SCF), tumor necrosis factor-alpha (TNF-alpha), and interleukin-1 (IL-1).
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
Molecular changes from NB-UVB thearpy [ Time Frame: 2 years ]
We're assessing the histological and molecular changes of healthy and Vitiligo-lesion skin from NB-UVB therapy. The molecular markers include, but not limited to, KIT receptor, stem cell factor (SCF), tumor necrosis factor-lapha (TNF-alpha), and interleukin-1 (IL-1).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy
Official Title  ICMJE Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy
Brief Summary

Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients' quality of life across all degrees of involvement and severity. Phototherapy, such as Narrow band UVB (NB-UVB), is a clinically indicated treatment for skin lesions. NB-UVB treatment has been shown to promote repigmentation and normalize cellular behaviors. The investigators would like to analyze the change in protein expression and histological change in skin from NB-UVB treatment in participants with Vitiligo.

The investigators are recruiting participants with Vitiligo on the body, arms, and/or legs.

Detailed Description

This is a dermatology study of the effects of short-term NB-UVB treatment, standard phototherapy for Vitiligo patients. In the study, demographics information, three ascending dose of phototherapy, and small skin biopsies will be required of the participants.

For all enrolled participants, the starting dose of NB-UVB administered will be 250 mJ/cm2, which is the standard of care for patients with Vitiligo. The dose will be increased by 10% with each treatment, as long as there are no side effects with treatment such as burning or redness/ erythema. Small skin biopsies will be collected from normal skin and from affected skin from vitiligo participants at the baseline visit and 3 days after the conclusion of treatment; up to a total of 6 biopsies will be collected from each patient. Participants will be compensated for time and effort.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Participants diagnosed with Vitiligo who are enrolled in the study will receive phototherapy (NB-UVB), with the starting dose of 250 mJ/cm2. The dose will be increased by 10% with each treatment. Small skin samples will be collected before and after NB-UVB treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vitiligo
  • Dermatology/Skin - Other
Intervention  ICMJE Device: Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet
This is an investigator-initiated, single-blinded, ascending dose study of NB-UVB treatment for Vitiligo in adults of 3 treatments for one week. It is designed to measure the molecular changes and re-pigmentation in affected and normal skin of participants with Vitiligo and normal skin in healthy participants.
Study Arms  ICMJE Experimental: Phototherapy (NB-UVB)
Phototherapy (NB-UVB) will be administered for all enrolled subjects. The starting dosage will be 250 mJ/cm2. The dose will be increased by 10% with each treatment, as long as there are no side effects with treatment.
Intervention: Device: Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults 18 years or older with bilateral symmetrical vitiligo lesions, in general good health as determined by the Principal Investigator by medical history and physical exam.
  • Able to understand consent procedure
  • Able to comply with protocol activities

Exclusion Criteria:

  • Patients less than 18 years old
  • Patients not able to understand consent procedure
  • Patients unable to comply with protocol activities
  • Non-English speakers: the study assessments/questionnaires/evaluations are not scientifically validated in languages other than English.
  • Patients with a photosensitive disorder or on a medication which has been demonstrated in these patients to cause photosensitivity
  • Patients receiving concomitant phototherapy to test sites
  • Patient receiving topical medication to test sites within 2 weeks of study initiation
  • Patient receiving oral medications for vitiligo within 4 weeks prior to study initiation
  • Receipt of an investigation agent within the past 4 weeks (or within 5 half lives) prior to study initiation
  • Pregnant or nursing patients (self-reported)
  • Patient with significant medical history or concurrent illness that the investigator feels is not safe for study participation, including melanoma
  • Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy.
  • Patients with history of excessive scar or keloid formation in the past 10 years
  • Patients with known allergy to anesthetic used
  • Subjects with a pacemaker, implanted cardioverter-defibrillator, baroreflex activation device, cochlear implant, implanted bone growth stimulator, robotic limb prosthesis, subcutaneous GPS tracking device, electrodes implanted in the brain, attached electrodes in a subject undergoing cardiac defibrillation during the moment of skin color reading, or other device which may be disrupted by electrical current, UNLESS subject is kept "1 yard (one arm's length) from the main unit" of the spectrophotometer at all times, as specified in device approval letter.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ruizhi Wang 410-502-7546 CTReP@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03270241
Other Study ID Numbers  ICMJE IRB00133884
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The investigators are still deciding on what information to release to other researchers.
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Noori Kim, M.D Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP