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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nice

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2026-03-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 4

1. 1. 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.
2. 2. To assess the effect of combining HBO therapy with phototherapy on vitiligo activity assessed by VSAS score variation at 12 and 24 weeks of treatment.
3. 3. To assess the effect of combining HBO therapy with phototherapy on patient-reported outcome of vitiligo, as assessed by the change in VNS score at 12 and 24 weeks of treatment.
4. 4. To evaluate the tolerability of HBO therapy combined with phototherapy in the treatment of diffuse vitiligo, judged by the frequency and severity of adverse events occurring during treatment.

Conditions and MedDRA coding

Vitiligo

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 1. Men and women diagnosed with non-segmental vitiligo for at least for 3 months
2. 2. ≥ 18 years old
3. 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. 4. BSA ≥0.5% involvement on the face
5. 5. VASI ≥3
6. 6. Active and stable vitiligo
7. 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. 8. Affiliation to a social security system
9. 9. Signed informed consent
10. 10. Patient willing and able to attend all study visits

Exclusion criteria 12

1. 1. Immunocompromised patients
2. 2. Personal history of skin cancer or photo dermatosis
3. 3. Use of UVB photosensitizing drugs
4. 4. Concomitant dermatosis which, in the opinion of the investigator, may interfere with the evaluation of vitiligo
5. 5. Segmental or mixed vitiligo
6. 6. Patients with more than 33% of leucotrichia on the lesions
7. 7. Patients with contraindications to HBO therapy
8. 8. Any other pathological condition or therapeutic treatment identified during the initial consultation and considered a contraindication to hyperbaric exposure
9. 9. Patients with active infection or other systemic/ inflammatory disease
10. 10. Tuberculosis or latent tuberculosis
11. 11. Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship, deprived of freedom or with psychiatric condition
12. 12. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean percentage of change from baseline (CFB) of VASI at week 24.

Secondary endpoints 4

1. 1. Mean percentage of change from baseline (CFB) of VASI at week 12
2. 2. VSAS between baseline and each visit
3. 3. VNS between baseline and each visit
4. 4. Frequency and severity of adverse events collection

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

Sponsor organisation

Centre Hospitalier Universitaire De Nice

Address

4 Avenue Reine Victoria

City

Nice

Postcode

06000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Thierry Passeron

Public contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Thierry Passeron

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications