VitiligoNCT00622180
The Efficacy of Hand Narrow-Band Ultraviolet B (NBUVB) Versus Excilite Treatment in Vitiligo After Minigrafting on the Dorsal Hands
A study testing NBUVB and Monochromacitc Excimer light in people with Vitiligo, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- NBUVB and Monochromacitc Excimer light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
Dallas, Texas, 75390-8802
About this study
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
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.
Read the 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.
- Conditions
- Vitiligo
- Being tested
- NBUVB, Monochromacitc Excimer light
- Keywords
- Vitiligo, Light treatment for vitiligo, Excilite
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBUVBDevice
NBUVB hand foot box
Monochromacitc Excimer lightDevice
Treatment with Monochromacitc Excimer light
| Study group | Role | What they receive |
|---|---|---|
| Daavlin Right vs. Excilite Left | Active comparator | Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light. Receives: Device: NBUVB |
| Excilite Right vs. Daavlin Left | Active comparator | Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light Receives: Device: Monochromacitc Excimer light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Repigmentation of Target Lesion
This is measured using photography and Scion software calculations.
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Pandya, M.D., Principal investigator, UT Southwestern Medical Center at Dallas - Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622180
- Sponsor's protocol ID
- IRB file number 122007-003
- Other IDs
- 122007-003
- Status last verified
- Nov 2019
- First submitted
- 23 Jan 2008
- Last updated
- 5 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00622180
- Acronym / sponsor ID
- IRB file number 122007-003
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Light treatment for vitiligo, Excilite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Posted 5 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daavlin Right vs. Excilite Left | Active comparator | Device: NBUVBRight hand treated with narrow-band UVB light and left hand treated with focal 308nm light. |
| Excilite Right vs. Daavlin Left | Active comparator | Device: Monochromacitc Excimer lightRight hand treated with focal 308-nm light and left hand treated with narrow-band UVB light |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBUVBNBUVB hand foot box | Device | Daavlin Right vs. Excilite Left |
| Monochromacitc Excimer lightTreatment with Monochromacitc Excimer light | Device | Excilite Right vs. Daavlin Left |
Primary outcome
Percent Repigmentation of Target Lesion
Time frame: 25 weeks
This is measured using photography and Scion software calculations.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Pandya, M.D. principal investigator
UT Southwestern Medical Center at Dallas - Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NBUVB and Monochromacitc Excimer light in people with Vitiligo, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Repigmentation of Target Lesion (time frame: 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.