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A study to evaluate the effectiveness of oxygen and narrow-band UVB phototherapy for treating patients with diffuse vitiligo

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on the treatment of vitiligo, a condition where the skin loses its natural color due to the loss of pigment-producing cells. The research aims to evaluate how a combination of two different treatments works together to manage this condition. The treatments being tested are hyperbaric oxygen therapy, which involves breathing oxygen in a pressurized chamber, and narrowband ultraviolet B therapy, a type of light therapy used on the skin.

Participants in this study will undergo a period of treatment lasting 24 weeks. During this time, the combination of pressurized oxygen and light therapy will be applied to assess how well they help restore skin color. The process involves regular visits to monitor the skin's appearance and any changes in the affected areas over the course of the intervention.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of the treatment phase

    The treatment for vitiligo, a condition that causes loss of skin color, begins with a combination of two therapies.

    The first therapy is hyperbaric oxygen (HBO), which involves breathing 100% oxygen in a specialized pressurized chamber.

  2. Step 2

    Combined therapy sessions

    The hyperbaric oxygen treatment is performed alongside phototherapy, which uses specific light to treat the skin.

    These sessions are conducted over a total period of 24 weeks.

  3. Step 3

    Monitoring and evaluation

    The progress of the skin is measured using the Vitiligo Area Scoring Index (VASI), a method to track the extent of the skin color changes.

    Assessments of the skin area and color are conducted at 12 weeks and at the conclusion of the 24-week period.

    Any adverse events, which are unexpected side effects or health changes, are recorded throughout the process.

Who can join the trial?

13 criteria

  • You must be a man or a woman who has been diagnosed with non-segmental vitiligo, which is a type of skin condition that causes white patches on different parts of the body rather than being limited to just one specific area or stripe.
  • You must have had this condition for at least 3 months.
  • You must be at least 18 years old.
  • The body surface area, or the total amount of skin affected, must be between 4% and 60% of your body.
  • The skin patches must not be located on the palms of your hands, the soles of your feet, or the back of your feet.
  • There must be at least 0.5% of the skin affected on your face.
  • Your Vitiligo Area Scoring Index (VASI), which is a special measurement used to track the severity and extent of the skin patches, must be 3 or higher.
  • Your condition must be active and stable, meaning the skin changes are currently happening but are not changing rapidly or unpredictably.
  • Women who are able to become pregnant must have used an effective form of birth control, such as the pill, an implant, an IUD, condoms, or have had their tubes tied, for more than one month before starting.
  • A urine pregnancy test, which checks for a specific hormone called βHCG that shows if someone is pregnant, will be required.
  • You must be covered by a social security system.
  • You must be willing and able to attend all scheduled visits for the study.
  • You must provide a signed informed consent, which is a formal document where you agree to participate after understanding all the details of the study.

Who cannot join the trial?

15 criteria

  • People with a weakened immune system, which means the body's natural defense system against germs is not working properly.
  • People who have tuberculosis (a serious infection that usually affects the lungs) or a latent tuberculosis infection (where the bacteria are in the body but are "sleeping" and not currently making the person sick).
  • Women who are pregnant or breastfeeding.
  • Minors, which refers to children or anyone under the legal age of adulthood.
  • Adults who are under guardianship (people who require a legal representative to make decisions for them).
  • People who are deprived of freedom (such as those in prison) or those with a psychiatric condition (mental health disorders).
  • People currently taking part in other medical studies involving drugs that might interfere with the results of this study.
  • Anyone with a personal history of skin cancer or photo dermatosis (a skin condition or reaction caused by exposure to light).
  • People using UVB photosensitizing drugs, which are medicines that make the skin more sensitive to sunlight.
  • People with another dermatosis (any disease or condition affecting the skin) that the doctor believes might make it difficult to see how the vitiligo is changing.
  • People with segmental or mixed vitiligo, which are specific types or patterns of the skin condition.
  • People with more than 33% leucotrichia on their skin patches, which means having white or colorless hair growing in the affected areas.
  • People who have medical reasons why they cannot undergo hyperbaric oxygen (HBO) therapy (a treatment where a person breathes pure oxygen in a pressurized chamber).
  • Any other health problem or medical treatment discovered during the first visit that makes it unsafe to use the pressure chamber.
  • People with an active infection or other systemic or inflammatory diseases (conditions that affect the whole body or cause swelling and redness throughout the body).
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Investigated drugs

  • Oxygen

    is a gas that is breathed in through a mask or device. In this study, it is used in a special pressurized chamber to help treat skin patches caused by vitiligo.

  • Narrowband UVB phototherapy

    is a type of light treatment that uses a specific wavelength of ultraviolet light to help restore skin color.

What is already known about the treatment

Oxygen - This substance is administered as a compressed gas that is breathed in through a mask or specialized breathing apparatus. It is a widely used medical gas that helps support life by increasing the amount of air available to the body. In this context, it is used to increase oxygen levels in the blood and tissues, which helps cells function better and supports the body's natural healing processes. It is classified as a medicinal gas used to treat conditions where oxygen levels in the body are too low.

Investigated diseases

Vitiligo - This condition occurs when the cells that produce skin color stop working or die. As a result, patches of skin lose their natural pigment and appear white. The patches can appear anywhere on the body and may grow in size over time. In some cases, the loss of color can spread to different areas of the skin. The pattern of these white patches can vary from person to person.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524709-34-00Protocol code25-AOI-MED-02Estimated enrolment5 patientsSponsorCentre Hospitalier Universitaire De Nice

sourced from the EU Clinical Trials Register and site verification

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