Authorised Therapeutic exploratory (Phase II) Vitiligo

Mitochondrial network modulation approach using hyperbaric oxygen (HBO) therapy and NNbUVB for treating vitiligo

EU CTIS ID: 2025-524709-34-00

What this study is testing

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.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Men and women diagnosed with non-segmental vitiligo for at least for 3 months
  • 10. Patient willing and able to attend all study visits
  • 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,
  • 4. BSA ≥0.5% involvement on the face
  • 5. VASI ≥3

You likely can't join if

  • 1. Immunocompromised patients
  • 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.
  • 2. Personal history of skin cancer or photo dermatosis
  • 3. Use of UVB photosensitizing drugs
See the full eligibility criteria
Who can join
  • 1. Men and women diagnosed with non-segmental vitiligo for at least for 3 months
  • 10. Patient willing and able to attend all study visits
  • 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,
  • 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
What rules you out
  • 1. Immunocompromised patients
  • 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.
  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.