Clinical trial NCT03270241: Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy
Official title: Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Dermatology/Skin - Other
Keywords: Vitiligo
Dermatology
Johns Hopkins
Compensation
Paid
Phototherapy
NB-UVB
Light treatment
Skin
Biopsies
Money
Short-term
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Molecular Changes From NB-UVB Therapy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Noori Kim, M.D
role: PRINCIPAL_INVESTIGATOR
References: