Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

Vitiligo Clinical Trial

Official title:

Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270241
• Other study ID #: IRB00133884
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: March 14, 2023

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 14, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatology/Skin - Other
• Vitiligo

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Outpatient Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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