A Phase 2/3 interventional study of OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL in Vitiligo Vulgaris, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 2/3, Interventional, and Treatment
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.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 5 is below the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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.
Drug: OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL
Throughout the study, there will be a total of 6 visits conducted: selection, inclusion, week 4, week 8, week 12 and week 24.
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.
Time frame: at 24 weeks
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.
Time frame: 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
Time frame: at 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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