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| ID | Type | Description | Link |
|---|---|---|---|
| 122007-003 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daavlin Right vs. Excilite Left | Active Comparator | Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light. |
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| Excilite Right vs. Daavlin Left | Active Comparator | Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBUVB | Device | NBUVB hand foot box |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Repigmentation of Target Lesion | This is measured using photography and Scion software calculations. | 25 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Pandya, M.D. | UT Southwestern Medical Center at Dallas - Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials | Dallas | Texas | 75390-8802 | United States |
It was our hope to enroll 26 Participants but only 13 was enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daavlin Right vs. Excilite Left | Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light. |
| FG001 | Excilite Right vs. Daavlin Left | Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Monochromacitc Excimer light |
| Device |
Treatment with Monochromacitc Excimer light |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Repigmentation of Target Lesion | This is measured using photography and Scion software calculations. | Posted | Mean | Standard Deviation | percentage of repigmentation | 25 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daavlin vs. Excilite | Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light. Daavlin Spectra UVB Hand/Foot Box : Narrow-band ultraviolet B hand box Excilite Focal 308-nm light : Excilite Focal 308-nm light | 0 | 6 | 0 | 6 | ||
| EG001 | Excilite vs. Daavlin | Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light Excilite Focal 308-nm light : Excilite Focal 308-nm light Daavlin Spectra UVB Hand/Foot Box : Narrow-band ultraviolet B hand box | 0 | 7 | 0 | 7 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amit Pandya, M.D. | UT Southwestern Medical Center at Dallas | 214-645-8300 | amit.pandya@utsouthwestern.edu |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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