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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL | Drug | Throughout the study, there will be a total of 6 visits conducted: selection, inclusion, week 4, week 8, week 12 and week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 12 weeks |
| frequency of adverse events occurring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thierry Passeron, PhD | Contact | +33492036488 | passeron.t@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thierry Passeron, PhD | Dermatologie, Hopital Archet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Nice | Alpes-maritimes | 06200 | France |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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.
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To evaluate the tolerability of HBO therapy combined with phototherapy in the treatment of diffuse vitiligo, judged by the frequency of adverse events occurring
| at 24 weeks |