Status:
COMPLETED
Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy
Lead Sponsor:
Johns Hopkins University
Conditions:
Vitiligo
Dermatology/Skin - Other
Eligibility:
All Genders
18-100 years
Phase:
NA
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), ...
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, an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03270241
Start Date
October 1 2017
End Date
March 14 2023
Last Update
January 9 2024
Active Locations (1)
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1
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21287