N/A
N=10
Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy
Vitiligo · Dermatology/Skin - Other
Bottom Line
View on ClinicalTrials.gov: NCT03270241 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Molecular Changes From NB-UVB Therapy
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Molecular Changes From NB-UVB Therapy |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03270241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.