Trial Outcomes & Findings for The Efficacy of Hand Narrow-Band Ultraviolet B (NBUVB) Versus Excilite Treatment in Vitiligo After Minigrafting on the Dorsal Hands (NCT NCT00622180)

Results Overview

This is measured using photography and Scion software calculations.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

25 weeks

Results posted on

2019-11-05

It was our hope to enroll 26 Participants but only 13 was enrolled.

Participant milestones
Measure	Daavlin Right vs. Excilite Left Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light.	Excilite Right vs. Daavlin Left Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light
Overall Study STARTED	6	7
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal
Measure	Daavlin Right vs. Excilite Left Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light.	Excilite Right vs. Daavlin Left Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light
Overall Study Lost to Follow-up	1	2

The Efficacy of Hand Narrow-Band Ultraviolet B (NBUVB) Versus Excilite Treatment in Vitiligo After Minigrafting on the Dorsal Hands

Baseline characteristics by cohort
Measure	The Efficacy of Hand NBUVB Vs. Excilite Treatment in Vitiligo n=13 Participants Light therapy with the NBUVB hand-foot box to one hand and the Excilite to the other hand three times a week on non-consecutive days for a total of 12 weeks. The light will be dosed as follows: starting dose for NBUVB will be 200 mJ/cm2 with subsequent dose increases of 15% per treatment as tolerated. For the Excilite device, the starting dose will be 200 mJ with subsequent dose increases of 50 mJ per treatment as tolerated.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	47 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

Timeframe: 25 weeks

This is measured using photography and Scion software calculations.

Outcome measures
Measure	NBUVB n=13 Participants Treatment with NBUVB	Monochromatic Excimer Light n=13 Participants One hand treated with monochromatic excimer light
Percent Repigmentation of Target Lesion	0.21 percentage of repigmentation Standard Deviation 0.35	0.17 percentage of repigmentation Standard Deviation 0.38

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

UT Southwestern Medical Center at Dallas

Phone: 214-645-8300