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Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03270241
Recruitment Status : Active, not recruiting
First Posted : September 1, 2017
Last Update Posted : June 30, 2022
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Vitiligo Dermatology/Skin - Other Device: Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03270241

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United States, Maryland
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Noori Kim, M.D Johns Hopkins University
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Responsible Party: Johns Hopkins University Identifier: NCT03270241    
Other Study ID Numbers: IRB00133884
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators are still deciding on what information to release to other researchers.

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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
Keywords provided by Johns Hopkins University:
Johns Hopkins
Light treatment
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases