Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

NCT03270241 | Completed Results FDA Device

• 1 other identifier: IRB00133884
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo; Dermatology/Skin - Other

Keywords

Vitiligo; Dermatology; Johns Hopkins; Compensation; Paid; Phototherapy; NB-UVB; Light treatment; Skin; Biopsies; Money; Short-term

Outcome Measures

Primary Outcomes (1)

• Molecular Changes From NB-UVB Therapy

  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).

  2 years

Study Arms (1)

Phototherapy (NB-UVB)

EXPERIMENTAL

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

Interventions

Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet DEVICE

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.

Phototherapy (NB-UVB)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Ruizhi Wang
• Organization: Johns Hopkins Medicine Dermatology Cutaneous Translational Research Program

rwang@jhmi.edu

4105027546

Study Officials

• Noori Kim, M.D

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 1, 2017
• Study Start: October 1, 2017
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-12

Locations

US (1)