OXYGEN for Vitiligo

Inclusion criteria

• {"criterion_text":"- 1.\tMen and women diagnosed with non-segmental vitiligo for at least for 3 months"}
• {"criterion_text":"- 10.\tPatient willing and able to attend all study visits"}
• {"criterion_text":"- 2.\t≥ 18 years old"}
• {"criterion_text":"- 3.\tBody 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,"}
• {"criterion_text":"- 4.\tBSA ≥0.5% involvement on the face"}
• {"criterion_text":"- 5.\tVASI ≥3"}
• {"criterion_text":"- 6.\tActive and stable vitiligo"}
• {"criterion_text":"- 7.\tFor 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"}
• {"criterion_text":"- 8.\tAffiliation to a social security system"}
• {"criterion_text":"- 9.\tSigned informed consent"}

Exclusion criteria

• {"criterion_text":"- 1.\tImmunocompromised patients"}
• {"criterion_text":"- 10.\tTuberculosis or latent tuberculosis"}
• {"criterion_text":"- 11.\tVulnerable people: pregnant or breast-feeding women, minors, adult under guardianship, deprived of freedom or with psychiatric condition"}
• {"criterion_text":"- 12.\tParticipants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation."}
• {"criterion_text":"- 2.\tPersonal history of skin cancer or photo dermatosis"}
• {"criterion_text":"- 3.\tUse of UVB photosensitizing drugs"}
• {"criterion_text":"- 4.\tConcomitant dermatosis which, in the opinion of the investigator, may interfere with the evaluation of vitiligo"}
• {"criterion_text":"- 5.\tSegmental or mixed vitiligo"}
• {"criterion_text":"- 6.\tPatients with more than 33% of leucotrichia on the lesions"}
• {"criterion_text":"- 7.\tPatients with contraindications to HBO therapy"}
• {"criterion_text":"- 8.\tAny other pathological condition or therapeutic treatment identified during the initial consultation and considered a contraindication to hyperbaric exposure"}
• {"criterion_text":"- 9.\tPatients with active infection or other systemic/ inflammatory disease"}

Primary endpoints

• {"endpoint_text":"- Mean percentage of change from baseline (CFB) of VASI at week 24.","definition_or_measurement_approach":"Mean percentage change from baseline of the Vitiligo Area Scoring Index (VASI) measured at week 24 (change from baseline, CFB)."}

Secondary endpoints

• {"endpoint_text":"- 1.\tMean percentage of change from baseline (CFB) of VASI at week 12","definition_or_measurement_approach":"Mean percentage change from baseline of VASI measured at week 12 (CFB)."}
• {"endpoint_text":"- 2.\tVSAS between baseline and each visit","definition_or_measurement_approach":"Variation in Vitiligo Signs Activity Score (VSAS) between baseline and each visit (assessed at weeks 12 and 24 as per translations)."}
• {"endpoint_text":"- 3.\tVNS between baseline and each visit","definition_or_measurement_approach":"Variation in Vitiligo Numeric Scale (VNS) between baseline and each visit (assessed at weeks 12 and 24)."}
• {"endpoint_text":"- 4.\tFrequency and severity of adverse events collection","definition_or_measurement_approach":"Collection of adverse events with assessment of frequency and severity; clinical examination and AE collection at weeks 12 and 24."}

France

Earliest CTIS Part Ii Submission Date

27-01-2026

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

56

Number Of Sites

1

Number Of Participants

5

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nice

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France