Mitochondrial Network Modulation Approach Using Hyperbaric Oxygen (HBO) Therapy and Nb-UVB for Treating Vitiligo

NCT07557693 | Not Yet Recruiting Phase 2

• 1 other identifier: 25-AOIMED-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• VASI at 12 weeks

  at 12 weeks

• frequency of adverse events occurring

  at 24 weeks

Study Arms (1)

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.

Drug: OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL

Interventions

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.

Oxygenotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes-maritimes, 06200, France

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thierry Passeron, PhD

  Dermatologie, Hopital Archet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Passeron, PhD

CONTACT

+33492036488; passeron.t@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)