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

Primary Purpose

Vitiligo

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NBUVB

Monochromacitc Excimer light

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Light treatment for vitiligo, Excilite

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Daavlin Right vs. Excilite Left

Excilite Right vs. Daavlin Left

Arm Description

Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light.

Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light

Outcomes

Primary Outcome Measures

Percent Repigmentation of Target Lesion

This is measured using photography and Scion software calculations.

Secondary Outcome Measures

Full Information

NCT ID

NCT00622180

First Posted

January 23, 2008

Last Updated

November 4, 2019

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00622180

Brief Title

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

Official Title

The Efficacy of Hand-Foot Narrow-Band Ultraviolet B (UVB) Versus Focal 308-nm Treatment in Inducing Repigmentation of Vitiligo After Minigrafting on the Dorsal Hands

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitiligo

Keywords

Vitiligo, Light treatment for vitiligo, Excilite

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daavlin Right vs. Excilite Left

Arm Type

Active Comparator

Arm Description

Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light.

Arm Title

Excilite Right vs. Daavlin Left

Arm Type

Active Comparator

Arm Description

Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light

Intervention Type

Device

Intervention Name(s)

NBUVB

Intervention Description

NBUVB hand foot box

Intervention Type

Device

Intervention Name(s)

Monochromacitc Excimer light

Intervention Description

Treatment with Monochromacitc Excimer light

Primary Outcome Measure Information:

Title

Percent Repigmentation of Target Lesion

Description

This is measured using photography and Scion software calculations.

Time Frame

25 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amit Pandya, M.D.

Organizational Affiliation

UT Southwestern Medical Center at Dallas - Department of Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-8802

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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