VitiligoPhase 3NCT00696358
Excimer Lamp Versus Excimer Laser in Vitiligo Treatment
A Phase 3 study testing 308nm excimer lamp and 308nm excimer laser in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in treating vitiligo. They have the same wavelength but the type of emission of the photons is different. To date there is no direct comparative data concerning these two devices in this indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- 308nm excimer lamp and 308nm excimer laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2009to 15 Jun 2010
- Phase
- Phase 3
- 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
- patient above 18
- vitiligo for more than 3 months
- at least 2 vitiligo symmetric patches more than 10cm²
- to read and understand the inform consent
- to have a social security number
- non pregnant for women
Who cannot join
- pregnant women
- keloids
- history of radiotherapy or skin cancer in the treated areas
- treatment for vitiligo in the past 4 weeks
- phototherapy in the past 12 weeks; history of photodermatosis
- treatment inducing photosensibilization
- immunosuppression
- patient who participated in a study in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo
308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in treating vitiligo. They have the same wavelength but the type of emission of the photons is different. To date there is no direct comparative data concerning these two devices in this indication.
The aim of the study is to make an intra-individual prospective comparison between these two phototherapies.
- Conditions
- Vitiligo
- Being tested
- 308nm excimer lamp, 308nm excimer laser
- Keywords
- Vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
308nm excimer lampRadiation
50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks
308nm excimer laserRadiation
50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks (same doses will be used between the 2 arms)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 308 nm excimer lamp Receives: Radiation: 308nm excimer lamp |
| B | Active comparator | 308 nm excimer laser Receives: Radiation: 308nm excimer laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation rate in the treated areas
Measured: 12 weeks
Secondary outcomes (1)
Tolerance and safety of the treatments
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study start17 Mar 2009
- Primary completion25 Nov 2009
- Study completion15 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 3
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696358
- Sponsor's protocol ID
- NICE-VIT1
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2008
- Last updated
- 16 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT00696358
- Acronym / sponsor ID
- NICE-VIT1
- Conditions
- Vitiligo
- Keywords
- Vitiligo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 17 Mar 2009 (actual)
- Primary completion
- 25 Nov 2009 (actual)
- Study completion
- 15 Jun 2010 (actual)
- First posted
- 12 Jun 2008 (estimated)
- 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.
308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in treating vitiligo. They have the same wavelength but the type of emission of the photons is different. To date there is no direct comparative data concerning these two devices in this indication.
The aim of the study is to make an intra-individual prospective comparison between these two phototherapies.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Radiation: 308nm excimer lamp308 nm excimer lamp |
| B | Active comparator | Radiation: 308nm excimer laser308 nm excimer laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient above 18
- vitiligo for more than 3 months
- at least 2 vitiligo symmetric patches more than 10cm²
- to read and understand the inform consent
- to have a social security number
Key exclusion criteria (8 listed)
- pregnant women
- keloids
- history of radiotherapy or skin cancer in the treated areas
- treatment for vitiligo in the past 4 weeks
- phototherapy in the past 12 weeks; history of photodermatosis
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 |
|---|---|---|
| 308nm excimer lamp50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks | Radiation | A |
| 308nm excimer laser50 mJ/cm² below the MED (minimal erythemal dose) and progressive increase Twice a week for 12 weeks (same doses will be used between the 2 arms) | Radiation | B |
Primary outcome
Repigmentation rate in the treated areas
Time frame: 12 weeks
1 secondary outcome
Tolerance and safety of the treatments
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 308nm excimer lamp and 308nm excimer laser in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 6 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 16 Jun 2026. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Repigmentation rate in the treated areas (time frame: 12 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 16 Jun 2026.