Vitiligo VulgarisPhase 2/3MitOxyVitNCT07557693
Mitochondrial Network Modulation Approach Using Hyperbaric Oxygen (HBO) Therapy and Nb-UVB for Treating Vitiligo
A Phase 2/3 study testing OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL in people with Vitiligo Vulgaris, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. Achieving the best treatment outcomes for vitiligo involves addressing the autoimmune inflammatory response for stopping the depigmentation process and promoting the differentiation of melanocyte stem… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo Vulgaris
- What is being tested?
- OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 31 Mar 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- 1. Men and women diagnosed with non-segmental vitiligo for at least for 3 months 2. ≥ 18 years old 3. Body surface area (BSA) involvement between 4%-60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet, and 4. BSA ≥0.5% involvement on the face 5. VASI ≥3 6. Active and stable vitiligo 7. For women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed 8. Affiliation to a social security system 9. Signed informed consent 10. Patient willing and able to attend all study visits.
Who cannot join
- 1. Immunocompromised patients 2. Personal history of skin cancer or photo dermatosis 3. Use of UVB photosensitizing drugs 4. Concomitant dermatosis which, in the opinion of the investigator, may interfere with the evaluation of vitiligo 5. Segmental or mixed vitiligo 6. Patients with more than 33% of leucotrichia on the lesions 7. Patients with contraindications to HBO therapy 8. Any other pathological condition or therapeutic treatment identified during the initial consultation and considered a contraindication to hyperbaric exposure 9. Patients with active infection or other systemic/ inflammatory disease 10. Tuberculosis or latent tuberculosis 11. Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship, deprived of freedom or with psychiatric condition 12. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Nice
Nice, Alpes-maritimes, 06200
Passeron, PhD, +33492034688, passeron.t@chu-nice.fr
Emmanuelle Pradelli, pradelli.e@chu-nice.fr
About this study
Official title: MitOxyVit: Mitochondrial Network Modulation Approach Using Hyperbaric Oxygen (HBO) Therapy and Nb-UVB for Treating Vitiligo
Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. Achieving the best treatment outcomes for vitiligo involves addressing the autoimmune inflammatory response for stopping the depigmentation process and promoting the differentiation of melanocyte stem cells to induce re-pigmentation. The loss of melanocytes in vitiligo is a result of an autoimmune process. The pathogenesis includes genetic and environmental factors together with metabolic, and oxidative stress that trigger innate then adaptive immunity against melanocytes. No individual mechanism can sufficiently account for all parts of this complex disease; instead, the convergence theory which combines immunological, biochemical, and environmental factors in genetically predisposed participants has been proposed as a unifying approach to understanding the pathophysiology of vitiligo. None of these proposed theories are in themselves sufficient to explain the different vitiligo phenotypes; and the overall contribution of each of these processes is still under debate, although there is now consensus on the autoimmune nature of vitiligo: melanocytes from participants with vitiligo are more susceptible to oxidative stress which triggers the release of inflammatory cytokines that will lead to activation of the innate immune response and subsequently to adaptive immune response through activation of autoreactive cytotoxic CD8+ T cells against melanocytes via abnormal JAK/STAT pathway activation. Despite the efficacy of JAK inhibitors in blunting the anti-melanocyte immune response, skin repigmentation still takes more than 1-2 years, and the repigmentation remains very difficult to achieve in some body locations. To overcome this lack of efficacy in some locations and the need of long duration of treatment, additional therapeutic options are needed.
Considering that the immune process primarily contributes to depigmentation while ultraviolet (UV) radiation stimulates the differentiation and proliferation of melanocyte stem cells for re-pigmentation, a combination therapy using HBO and narrowband UVB (NbUVB) could offer an optimal approach for treating vitiligo patients. The primary objectif is to assess the therapeutic efficacy of combining hyperbaric oxygen (HBO) therapy with phototherapy for the treatment of diffuse vitiligo, as measured by the change in Vitiligo Area Scoring Index (VASI) after 24 weeks of intervention.
- 1- Recruitment of patients corresponding to the inclusion and exclusion criteria from the active file of vitiligo patients followed in the dermatology department of Nice University Hospital (Hopital Archet).
- 2- Consultation with a hyperbaric physician to verify the absence of contraindications to HBO therapy, and performance of a urine pregnancy test.
- 3- UVB 2 sessions per week over 24 weeks + HBO therapy 40 sessions over 8 weeks (1/d; 5/7)
- T0- Completion of VASI and VSAS clinical scores by a dermatologist.
- T1- VASI and VSAS scores after 12 weeks of treatment by a dermatologist.
- T2- VASI, VSAS and VNS scores after 24 weeks of treatment by a dermatologist.
- Conditions
- Vitiligo Vulgaris
- Being tested
- OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICALDrug
Throughout the study, there will be a total of 6 visits conducted: selection, inclusion, week 4, week 8, week 12 and week 24.
| Study group | Role | What they receive |
|---|---|---|
| Oxygenotherapy | Experimental | This protocol aims to enroll 5 participants with active or stable non-segmental vitiligo who will receive HBO and NbUVB twice a week. Throughout the study, there will be a total of 6 visits conducted: selection, inclusion, week 4, week 8, week 12 and week 24. Receives: Drug: OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitiligo Area Scoring Index (VASI)
To assess the therapeutic efficacy of combining hyperbaric oxygen (HBO) therapy with phototherapy for the treatment of diffuse vitiligo, as measured by the change in Vitiligo Area Scoring Index (VASI) after 24 weeks of intervention.
Measured: at 24 weeks
Secondary outcomes (2)
VASI at 12 weeks
To assess the efficacy of HBO therapy in combination with phototherapy in the treatment of diffuse vitiligo based on change in VASI score after 12 weeks of treatment.
Measured: at 12 weeks
frequency of adverse events occurring
To evaluate the tolerability of HBO therapy combined with phototherapy in the treatment of diffuse vitiligo, judged by the frequency of adverse events occurring
Measured: at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitiligo VulgarisStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will receive a total of 40 sessions of hyperbaric oxygen therapy (HBOT) spread over an 8-week period, in conjunction with narrowband UVB (NbUVB) treatment administered twice weekly throughout the study. Follow-up will include four clinic visits at the following time points: screening, enrollment (baseline), week 4, week 8, week 12, and week 24.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Passeron, PhD, Principal investigator, Dermatologie, Hopital Archet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557693
- Sponsor's protocol ID
- 25-AOIMED-02
- Acronym
- MitOxyVit
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitOxyVit: Mitochondrial Network Modulation Approach Using Hyperbaric Oxygen (HBO) Therapy and Nb-UVB for Treating Vitiligo
- ClinicalTrials.gov ID
- NCT07557693
- Acronym / sponsor ID
- MitOxyVit / 25-AOIMED-02
- Conditions
- Vitiligo Vulgaris
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 29 Apr 2026 (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.
Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. Achieving the best treatment outcomes for vitiligo involves addressing the autoimmune inflammatory response for stopping the depigmentation process and promoting the differentiation of melanocyte stem cells to induce re-pigmentation. The loss of melanocytes in vitiligo is a result of an autoimmune process. The pathogenesis includes genetic and environmental factors together with metabolic, and oxidative stress that trigger innate then adaptive immunity against melanocytes. No individual mechanism can sufficiently account for all parts of this complex disease; instead, the convergence theory which combines immunological, biochemical, and environmental factors in genetically predisposed participants has been proposed as a unifying approach to understanding the pathophysiology of vitiligo. None of these proposed theories are in themselves sufficient to explain the different vitiligo phenotypes; and the overall contribution of each of these processes is still under debate, although there is now consensus on the autoimmune nature of vitiligo: melanocytes from participants with vitiligo are more susceptible to oxidative stress which triggers the release of inflammatory cytokines that will lead to activation of the innate immune response and subsequently to adaptive immune response through activation of autoreactive cytotoxic CD8+ T cells against melanocytes via abnormal JAK/STAT pathway activation. Despite the efficacy of JAK inhibitors in blunting the anti-melanocyte immune response, skin repigmentation still takes more than 1-2 years, and the repigmentation remains very difficult to achieve in some body locations. To overcome this lack of efficacy in some locations and the need of long duration of treatment, additional therapeutic options are needed.
Considering that the immune process primarily contributes to depigmentation while ultraviolet (UV) radiation stimulates the differentiation and proliferation of melanocyte stem cells for re-pigmentation, a combination therapy using HBO and narrowband UVB (NbUVB) could offer an optimal approach for treating vitiligo patients. The primary objectif is to assess the therapeutic efficacy of combining hyperbaric oxygen (HBO) therapy with phototherapy for the treatment of diffuse vitiligo, as measured by the change in Vitiligo Area Scoring Index (VASI) after 24 weeks of intervention.
- 1- Recruitment of patients corresponding to the inclusion and exclusion criteria from the active file of vitiligo patients followed in the dermatology department of Nice University Hospital (Hopital Archet).
- 2- Consultation with a hyperbaric physician to verify the absence of contraindications to HBO therapy, and performance of a urine pregnancy test.
- 3- UVB 2 sessions per week over 24 weeks + HBO therapy 40 sessions over 8 weeks (1/d; 5/7)
- T0- Completion of VASI and VSAS clinical scores by a dermatologist.
- T1- VASI and VSAS scores after 12 weeks of treatment by a dermatologist.
- T2- VASI, VSAS and VNS scores after 24 weeks of treatment by a dermatologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will receive a total of 40 sessions of hyperbaric oxygen therapy (HBOT) spread over an 8-week period, in conjunction with narrowband UVB (NbUVB) treatment administered twice weekly throughout the study. Follow-up will include four clinic visits at the following time points: screening, enrollment (baseline), week 4, week 8, week 12, and week 24.
| Arm | Type | Receives |
|---|---|---|
| Oxygenotherapy | Experimental | Drug: OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICALThis protocol aims to enroll 5 participants with active or stable non-segmental vitiligo who will receive HBO and NbUVB twice a week. Throughout the study, there will be a total of 6 visits conducted: selection, inclusion, week 4, week 8, week 12 and week 24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Men and women diagnosed with non-segmental vitiligo for at least for 3 months 2. ≥ 18 years old 3. Body surface area (BSA) involvement between 4%-60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet, and 4. BSA ≥0.5% involvement on the face 5. VASI ≥3 6. Active and stable vitiligo 7. For women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed 8. Affiliation to a social security system 9. Signed informed consent 10. Patient willing and able to attend all study visits.
Key exclusion criteria (1 listed)
- 1. Immunocompromised patients 2. Personal history of skin cancer or photo dermatosis 3. Use of UVB photosensitizing drugs 4. Concomitant dermatosis which, in the opinion of the investigator, may interfere with the evaluation of vitiligo 5. Segmental or mixed vitiligo 6. Patients with more than 33% of leucotrichia on the lesions 7. Patients with contraindications to HBO therapy 8. Any other pathological condition or therapeutic treatment identified during the initial consultation and considered a contraindication to hyperbaric exposure 9. Patients with active infection or other systemic/ inflammatory disease 10. Tuberculosis or latent tuberculosis 11. Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship, deprived of freedom or with psychiatric condition 12. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation.
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 |
|---|---|---|
| OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICALThroughout the study, there will be a total of 6 visits conducted: selection, inclusion, week 4, week 8, week 12 and week 24. | Drug | Oxygenotherapy |
Primary outcome
Vitiligo Area Scoring Index (VASI)
Time frame: at 24 weeks
To assess the therapeutic efficacy of combining hyperbaric oxygen (HBO) therapy with phototherapy for the treatment of diffuse vitiligo, as measured by the change in Vitiligo Area Scoring Index (VASI) after 24 weeks of intervention.
2 secondary outcomes
VASI at 12 weeks
Time frame: at 12 weeks
frequency of adverse events occurring
Time frame: at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- 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.
Thierry Passeron, PhD principal investigator
Dermatologie, Hopital Archet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL in people with Vitiligo Vulgaris, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thierry Passeron, PhD (+33492036488, passeron.t@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitiligo Area Scoring Index (VASI) (time frame: at 24 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 Jun 2026.