Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

NCT ID: NCT03270241

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2023-03-14

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.

Conditions

Vitiligo; Dermatology/Skin - Other

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noori Kim, M.D

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00133884

Identifier Type: -

Identifier Source: org_study_id