Generalized VitiligoNCT05238077
Comparing the Efficacy of Visible Light-Ultraviolet A1 Light Versus Narrowband-Ultraviolet B on Generalized Vitiligo
A study testing Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy in people with Generalized Vitiligo, run by Henry Ford Health System at 1 site in United States.
Trial summary
As part of this study, you may have a procedure called phototherapy which involves either VL-UVA or NB-UVB irradiation. NB-UVB phototherapy is not experimental in vitiligo, but use of VL-UVA1 phototherapy in vitiligo is. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Vitiligo
- What is being tested?
- Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 2 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects ≥ 18 years of age with a diagnosis of generalized vitiligo
- Subjects on a stable topical/oral regimen for the past 3 months and continuing on a stable regimen
- Subjects able to understand the requirements of the study
- Subjects able and willing to sign informed consent
Who cannot join
- Subjects on photosensitizing medications
- Subjects receiving any concurrent phototherapy
- Subjects who plan to use tanning parlors or expose themselves to excess sunlight
- Subjects with known photosensitivity disorder
- Subjects with apparent phototoxicity
- Subjects with unstable vitiligo
Show all 9Show fewer
- Subjects currently using bleaching agents
- Subjects who are pregnant, lactating, or planning on becoming pregnant
- Subjects who in the opinion of the investigator/sub-investigator, are not appropriate candidates for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
Detroit, Michigan, 48202
About this study
Official title: Comparing the Efficacy of VL-UVA1 Versus NB-UVB on Inducing Repigmentation in Subjects With Generalized Vitiligo
As part of this study, you may have a procedure called phototherapy which involves either VL-UVA or NB-UVB irradiation. NB-UVB phototherapy is not experimental in vitiligo, but use of VL-UVA1 phototherapy in vitiligo is.
The purpose of this pilot study is to determine whether VL-UVA1 or NB-UVB phototherapy more efficiently induces repigmentation in patients with generalized vitiligo.
- Conditions
- Generalized Vitiligo
- Being tested
- Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapyProcedure or surgery
Patients will have different kinds of light shined on different areas
| Study group | Role | What they receive |
|---|---|---|
| VL-UVA1 vs NB-UVB | Other | Participants will be treated with both VL-UVA and NB-UVB on different areas Receives: Procedure: Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depigmentation of vitiligo lesion
Change in pigment will be assessed by colorimetry which measures change in pigment
Measured: 13 measurements over 26 visits
Change in melanin content of vitiligo lesion
Change in pigment will be assessed by diffuse reflectance spectroscopy which will measure the melanin content and dyschromia
Measured: 13 measurements over 26 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start26 Feb 2018
- Primary completion1 May 2020
- Study completion2 Jun 2020
Why it stopped: only one subject enrolled, decided to re-evaluate protocol design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized VitiligoStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- The subject serves as their own control.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat Hamzavi, M.D., Principal investigator, Henry Ford HS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238077
- Sponsor's protocol ID
- 11973
- Status last verified
- Feb 2022
- First submitted
- 22 Jul 2019
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of VL-UVA1 Versus NB-UVB on Inducing Repigmentation in Subjects With Generalized Vitiligo
- ClinicalTrials.gov ID
- NCT05238077
- Acronym / sponsor ID
- 11973
- Conditions
- Generalized Vitiligo
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: only one subject enrolled, decided to re-evaluate protocol design
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As part of this study, you may have a procedure called phototherapy which involves either VL-UVA or NB-UVB irradiation. NB-UVB phototherapy is not experimental in vitiligo, but use of VL-UVA1 phototherapy in vitiligo is.
The purpose of this pilot study is to determine whether VL-UVA1 or NB-UVB phototherapy more efficiently induces repigmentation in patients with generalized vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The subject serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| VL-UVA1 vs NB-UVB | Other | Procedure: Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapyParticipants will be treated with both VL-UVA and NB-UVB on different areas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects ≥ 18 years of age with a diagnosis of generalized vitiligo
- Subjects on a stable topical/oral regimen for the past 3 months and continuing on a stable regimen
- Subjects able to understand the requirements of the study
- Subjects able and willing to sign informed consent
Key exclusion criteria (9 listed)
- Subjects on photosensitizing medications
- Subjects receiving any concurrent phototherapy
- Subjects who plan to use tanning parlors or expose themselves to excess sunlight
- Subjects with known photosensitivity disorder
- Subjects with apparent phototoxicity
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 |
|---|---|---|
| Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapyPatients will have different kinds of light shined on different areas | Procedure or surgery | VL-UVA1 vs NB-UVB |
Primary outcome
Change in depigmentation of vitiligo lesion
Time frame: 13 measurements over 26 visits
Change in pigment will be assessed by colorimetry which measures change in pigment
Change in melanin content of vitiligo lesion
Time frame: 13 measurements over 26 visits
Change in pigment will be assessed by diffuse reflectance spectroscopy which will measure the melanin content and dyschromia
Results and safety
The study was stopped early (reason given: only one subject enrolled, decided to re-evaluate protocol design). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Generalized Vitiligo
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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.
Iltefat Hamzavi, M.D. principal investigator
Henry Ford HS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy in people with Generalized Vitiligo, run by Henry Ford Health System 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Feb 2022. 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?
The study was stopped early (reason given: only one subject enrolled, decided to re-evaluate protocol design). Results are not available in the source record.
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?
Change in depigmentation of vitiligo lesion (time frame: 13 measurements over 26 visits). The study lists 2 primary outcomes in all. 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 14 Feb 2022.