Vitiligo
Conditions
Keywords
Vitiligo, Light treatment for vitiligo, Excilite
Brief summary
To assess over a 25-week period the efficacy of hand-foot narrow-band ultraviolet B light versus focal 308-nm light treatment in inducing the return of pigment in vitiligo after skin minigraft transplants to the backs of the hands in patients with light brown to black skin. Subject will undergo treatment for 13 weeks.
Detailed description
Prospective investigator-blinded study involving 13 adult male and female subjects with vitiligo on the backs of both hands. Punch minigrafting will be performed on both hands taking skin from the thighs and/or buttocks. Light treatments will be administered starting at week one after grafting. One hand will receive narrow-band ultraviolet B light and the other will receive focal 308-nm light treatments. Light treatments will be administered 3 times per week for 12 weeks. A long term follow-up visit will be completed at week 25. The investigator will evaluate the subjects at week 4, 7, 13 and 25 in addition to screening and baseline evaluations/procedures.
Interventions
DEVICENBUVB
NBUVB hand foot box
DEVICEMonochromacitc Excimer light
Treatment with Monochromacitc Excimer light
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male and female subjects 18 years of age or older * skin type III-VI * vitiligo on both dorsal hands * history of stable vitiligo ( no new lesions and no more than 10% enlargement of existing lesions) for six months with an absence of Kebner phenomenon (new lesions appearing after trauma to the skin) * refractory to topical steroids and immunomodulators
Exclusion criteria
* pregnant and/or breast-feeding females * history of skin cancer * history of taking photosensitizing medications * history of recent phototherapy (light therapy) or topical medications within one month prior to enrollment * history of organ transplantation * history of failed vitiligo skin transplantation * history of segmental vitiligo * history of 12 or more continuous light treatments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Repigmentation of Target Lesion | 25 weeks | This is measured using photography and Scion software calculations. |
Countries
United States
Participant flow
Pre-assignment details
It was our hope to enroll 26 Participants but only 13 was enrolled.
Participants by arm
| Arm | Count |
|---|---|
| The Efficacy of Hand NBUVB Vs. Excilite Treatment in Vitiligo 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. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | The Efficacy of Hand NBUVB Vs. Excilite Treatment in Vitiligo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
Primary
Percent Repigmentation of Target Lesion
This is measured using photography and Scion software calculations.
Time frame: 25 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NBUVB | Percent Repigmentation of Target Lesion | 0.21 percentage of repigmentation | Standard Deviation 0.35 |
| Monochromatic Excimer Light | Percent Repigmentation of Target Lesion | 0.17 percentage of repigmentation | Standard Deviation 0.38 |