An interventional study of Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet in Vitiligo and Dermatology/Skin - Other, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
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.
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).
Time frame: 2 years
| Milestone | Phototherapy (NB-UVB) |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
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).
No measurements were reported for this outcome.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phototherapy (NB-UVB) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Event | Phototherapy (NB-UVB) |
|---|---|
| Wound InfectionInfections and infestations | 1/10 |
| Age, Continuous(years) | Phototherapy (NB-UVB) |
|---|---|
| Mean | 49.6 ± 10.62 |
| Sex: Female, Male(Participants) | Phototherapy (NB-UVB) |
|---|---|
| Female | 5 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Phototherapy (NB-UVB) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 4 |
| More than one race | 1 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Phototherapy (NB-UVB) |
|---|---|
| United States | 10 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — The investigators are still deciding on what information to release to other researchers.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johns Hopkins University