Trial Outcomes & Findings for Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy (NCT NCT03270241)

Last Updated: 2024-01-09

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

2 years

Results posted on

2024-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Phototherapy (NB-UVB) 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. 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phototherapy (NB-UVB) n=10 Participants 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. 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.
Age, Continuous	49.6 years STANDARD_DEVIATION 10.62 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Data was not collected.

Outcome measures

Outcome data not reported

Adverse Events

Phototherapy (NB-UVB)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Phototherapy (NB-UVB) n=10 participants at risk 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. 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.
Infections and infestations Wound Infection	10.0% 1/10 • Number of events 1 • 1 year

Additional Information

Ruizhi Wang

Johns Hopkins Medicine Dermatology Cutaneous Translational Research Program

Phone: 4105027546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place