VitiligoVitisodNCT03941808
Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo.
A study testing Glisodin tablet in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The role of the oxidative stress in vitiligo is supported by many studies but robust data are lacking concerning their interest as therapeutic agents. The objective of the study is to compare the association of GLISODIN (a gastro-protected superoxide dismutase) and Nb-UVB to Nb-UVB and placebo for treating vitiligo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Glisodin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2019to 1 Dec 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
- Vitiligo
- Vitiligo, SOD, UVB
- Non-segmental vitiligo with BSA>5%
Who cannot join
- Criteria of non-inclusion
- Segmental or mixed vitiligo
- Pregnancy
- Vitiligo lesions localized only on hands and feet
- Immuno-suppressive drugs
- Corticosteroids
Show all 10Show fewer
- Photosensitive drugs
- Photodermatosis
- Personal history of skin cancer
- Allergy to gluten
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo. A Randomized Double Blind Placebo Controlled Monocentric Study
The role of the oxidative stress in vitiligo is supported by many studies but robust data are lacking concerning their interest as therapeutic agents. The objective of the study is to compare the association of GLISODIN (a gastro-protected superoxide dismutase) and Nb-UVB to Nb-UVB and placebo for treating vitiligo.
Adult patients with non-segmental vitiligo affecting more than 5% of body surface area will be included.
The main criteria of evaluation will be the VES score at 6 months compared to baseline in both groups.
- Conditions
- Vitiligo
- Being tested
- Glisodin tablet, Placebo tablet
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glisodin tabletDrug
4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
Placebo tabletDrug
4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months Receives: Drug: Glisodin tablet |
| Placebo | Placebo comparator | 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation Vitiligo
Change from Baseline VES (Vitiligo Extend Score) at 6 months
Measured: At Baseline and at 6 weeks
Secondary outcomes (1)
Quality of life of patient
Change from baseline DLQI at 6 months
Measured: At Baseline and at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start17 Jun 2019
- Primary completion2 May 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Passeron Thierry, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941808
- Sponsor's protocol ID
- 19-PP-01
- Acronym
- Vitisod
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fontas E, Montaudie H, Passeron T. Oral gliadin-protected superoxide dismutase in addition to phototherapy for treating non-segmental vitiligo: A 24-week prospective randomized placebo-controlled study. J Eur Acad Dermatol Venereol. 2021 Aug;35(8):1725-1729. doi: 10.1111/jdv.17331. Epub 2021 May 13.
PubMed 33931900
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo. A Randomized Double Blind Placebo Controlled Monocentric Study
- ClinicalTrials.gov ID
- NCT03941808
- Acronym / sponsor ID
- Vitisod / 19-PP-01
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 2 May 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 8 May 2019 (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.
The role of the oxidative stress in vitiligo is supported by many studies but robust data are lacking concerning their interest as therapeutic agents. The objective of the study is to compare the association of GLISODIN (a gastro-protected superoxide dismutase) and Nb-UVB to Nb-UVB and placebo for treating vitiligo.
Adult patients with non-segmental vitiligo affecting more than 5% of body surface area will be included.
The main criteria of evaluation will be the VES score at 6 months compared to baseline in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: Glisodin tablet4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months |
| Placebo | Placebo comparator | Drug: Placebo tablet4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Vitiligo
- Vitiligo, SOD, UVB
- Non-segmental vitiligo with BSA>5%
Key exclusion criteria (10 listed)
- Criteria of non-inclusion
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 |
|---|---|---|
| Glisodin tablet4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months | Drug | Drug |
| Placebo tablet4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months | Drug | Placebo |
Primary outcome
Evaluation Vitiligo
Time frame: At Baseline and at 6 weeks
Change from Baseline VES (Vitiligo Extend Score) at 6 months
1 secondary outcome
Quality of life of patient
Time frame: At Baseline and at 6 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 24 Mar 2026.
- Results publication: PubMed 33931900Fontas E, Montaudie H, Passeron T. Oral gliadin-protected superoxide dismutase in addition to phototherapy for treating non-segmental vitiligo: A 24-week prospective randomized placebo-controlled study. J Eur Acad Dermatol Venereol. 2021 Aug;35(8):1725-1729. doi: 10.1111/jdv.17331. Epub 2021 May 13.
- Individual participant dataSharing planned: No
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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.
Passeron Thierry, PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glisodin tablet 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 3 inclusion and 10 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 24 Mar 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. Some participants in this study may receive a placebo. 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 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?
Evaluation Vitiligo (time frame: At Baseline and at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941808, which also lists 1 linked publication.
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 24 Mar 2026.