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A study testing pioglitazone for adults with non-segmental vitiligo to see if it works and is safe when used with light therapy

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 is looking at a condition called vitiligo, which is a skin disorder where patches of skin lose their color and become white. The study focuses specifically on non-segmental vitiligo, which is a type where the white patches appear on both sides of the body in a somewhat symmetrical pattern. The treatment being tested is a medication called pioglitazone, which is a type of medicine that affects how the body processes certain substances. This medication will be given as tablets and will be used together with light therapy treatment, which is a common way of treating vitiligo where the skin is exposed to specific types of light.

The purpose of this study is to find out if pioglitazone works well for treating non-segmental vitiligo, and also to check if it is safe and well-tolerated by people who take it. The study will particularly look at whether the medication can help improve the appearance of white patches on the face. People in this study will need to have tried at least one standard treatment for vitiligo before, such as creams containing corticosteroids or other specific medications, and these previous treatments will not have worked well enough for them.

During the study, participants will take pioglitazone tablets by mouth along with their light therapy treatment for a period of 16 weeks. The highest daily amount of the medication will be 15 milligrams. Throughout the study, doctors will measure how much the white patches on the face improve, particularly checking if they get at least 50 percent better compared to how they looked at the start. Women who could become pregnant will need to use reliable birth control methods during the study and for 30 days after taking the last dose of the medication. The study will check regularly to make sure the treatment is working and that participants are not having any problems with the medication.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and confirmation of eligibility

    Your medical history will be reviewed to confirm that you have non-segmental vitiligo, which is a condition causing loss of skin color in patches that appear on both sides of the body.

    The extent of depigmented areas on your face will be measured. Your face involvement must be at least 0.3% of body surface area. This measurement excludes the scalp, ears, neck, and lips, but includes the nose and eyelids.

    Your Total Vitiligo Scoring Index will be assessed. This is a measurement system that evaluates the extent and severity of vitiligo across your entire body. Your score must be at least 3.

    Your Facial Vitiligo Area Scoring Index will be calculated. This specifically measures vitiligo on your face. Your score must be at least 0.3.

    If you are female and able to become pregnant, a pregnancy test will be performed. The result must be negative to proceed.

    You will be asked to sign an informed consent document after receiving information about all aspects of the study.

  2. Step 2

    Discontinuation of other vitiligo treatments

    You will need to stop all other treatments for vitiligo according to specific waiting periods before the study begins.

    This discontinuation period will continue from the screening phase until your final follow-up visit.

  3. Step 3

    Beginning of treatment phase

    You will begin treatment with pioglitazone, which is a medication that activates specific receptors in your cells. This medication belongs to a group called thiazolidinediones.

    The medication will be provided as tablets for oral use.

    The dosage will be 15 mg per tablet.

    You will receive phototherapy treatment simultaneously with the pioglitazone medication. Phototherapy is a treatment that uses specific wavelengths of light on the skin.

  4. Step 4

    Regular monitoring during treatment

    If you are female and able to become pregnant, you will undergo pregnancy testing every 4 weeks throughout the entire study.

    Your vitiligo will be assessed regularly using the scoring systems mentioned earlier.

    Safety assessments will be performed to monitor how well you tolerate the medication.

  5. Step 5

    Assessment at week 16

    At week 16, your facial vitiligo will be evaluated to determine if there has been at least 50% improvement from the beginning of the study.

    This assessment uses the Facial Vitiligo Area Scoring Index to measure changes in the depigmented areas on your face.

  6. Step 6

    Continuation of treatment and contraception requirements

    If you are female and able to become pregnant, you must continue using a highly effective method of contraception throughout the study.

    This contraception requirement extends for at least 30 days after your last dose of pioglitazone.

  7. Step 7

    Final follow-up visit

    You will attend a final follow-up visit after completing the treatment phase.

    Final assessments of your vitiligo and overall health will be performed.

    After this visit, you may resume other vitiligo treatments if needed.

Who can join the trial?

11 criteria

  • You must be an adult between 18 years and 65 years of age, of any gender
  • You must have a confirmed diagnosis of non-segmental vitiligo, which is a type of vitiligo where white patches appear on both sides of your body in a scattered pattern, with areas where skin has lost its color
  • You must have vitiligo involvement on your face covering at least 0.3% of body surface area. The face includes your nose and eyelids but does not include your scalp, ears, neck, or lips
  • You must have a Total Vitiligo Scoring Index (T-VASI) of at least 3. This is a scoring system that measures how much of your body is affected by vitiligo and how much color has been lost
  • You must have a Facial Vitiligo Area Scoring Index (F-VASI) of at least 0.3. This measures how much vitiligo affects your face specifically
  • You must have previously tried at least one standard treatment for vitiligo, such as topical corticosteroids (steroid creams applied to the skin) or calcineurin inhibitors (immune-suppressing creams), and these treatments did not work well enough
  • You must be willing to sign an informed consent document, showing that you understand all important information about the study
  • You must agree to stop all other vitiligo treatments from the time you enter the study until your final follow-up visit
  • If you are a woman who can become pregnant, you must agree to use a highly effective birth control method throughout the study and for at least 30 days after your last dose of the study medication
  • If you are a woman who can become pregnant, you must have a negative pregnancy test at your first visit and then every 4 weeks during the entire study
  • If you are a woman who cannot become pregnant, you must meet at least one of these conditions: you have gone through menopause (no menstrual periods for at least 12 consecutive months), you have had surgery to remove your uterus and/or ovaries, or you have confirmed ovarian failure (your ovaries no longer function)

Who cannot join the trial?

11 criteria

  • Pregnancy or breastfeeding: Women who are pregnant or nursing a baby cannot participate in this study.
  • Heart problems: Patients with heart failure (when the heart cannot pump blood properly) or a history of serious heart conditions cannot join.
  • Liver disease: People with severe liver problems (the organ that cleans your blood and helps digest food) are not eligible.
  • Bladder cancer: Patients who have or had bladder cancer (cancer in the organ that stores urine) cannot participate.
  • Allergy to study medication: Anyone allergic to pioglitazone (the study medication) or similar medications cannot take part.
  • Diabetes type 1: Patients with type 1 diabetes (a condition where the body does not produce insulin) are excluded.
  • Severe kidney disease: People with serious kidney problems (organs that filter waste from blood) cannot join.
  • Active infections: Patients with ongoing serious infections are not eligible.
  • Other skin conditions: People with other active skin diseases in the treatment area cannot participate.
  • Recent medications: Patients who recently used certain medications that affect the immune system or skin cannot join immediately.
  • Inability to follow treatment: People who cannot attend regular visits or follow the phototherapy (light treatment) schedule are excluded.
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Investigated drugs

  • Pioglitazone

    is a medication that belongs to a group of medicines called thiazolidinediones. It works by activating a specific protein in your body called PPARγ. In this study, it is being tested to see if it can help treat vitiligo, a condition that causes loss of skin color in patches. The medication will be used together with phototherapy, which is a treatment that uses light.

  • Phototherapy

    is a treatment that uses special light to treat skin conditions. In this study, it will be used along with pioglitazone to see if the combination can help improve vitiligo.

What is already known about the treatment

Pioglitazone – Pioglitazone is an oral medication taken by mouth that belongs to a class of drugs called thiazolidinediones, which work by activating a specific protein called PPARγ in cells to help regulate various body processes. Originally approved for treating type 2 diabetes by improving how the body uses insulin, this medication is now being studied in clinical trials for treating vitiligo, a skin condition where patches of skin lose their color. In this research study, pioglitazone is being tested in combination with light therapy to see if activating PPARγ can help restore skin pigmentation in adults with non-segmental vitiligo. The medication works at the cellular level by binding to PPARγ receptors, which may help promote the survival and function of pigment-producing cells in the skin.

Investigated diseases

Vitiligo – Vitiligo is a skin condition in which patches of skin lose their natural color and become white. This happens because the cells that produce skin pigment, called melanocytes, are destroyed or stop functioning properly. The white patches can appear anywhere on the body, including the face, hands, arms, and feet. The condition typically develops gradually, with patches slowly spreading over time, though the rate and extent of color loss is unpredictable. Vitiligo can affect people of any skin type, but the white patches are more noticeable in people with darker skin. The condition is not contagious and does not cause physical discomfort, though it may affect a person's appearance and emotional well-being.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523266-24-00Protocol code2025-523266-24-00Estimated enrolment60 patientsSponsorI.F.O. Istituti Fisioterapici Ospitalieri

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