AuthorisedTherapeutic exploratory (Phase II)Interventional

“A phase 2 multi-center study investigating the efficacy, safety and tolerability of pioglitazone in adult participants with non-segmental vitiligo”

This study is investigating a medicine called pioglitazone, which is already used for other health conditions, to see if it can help adults who have non-segmental vitiligo. Vitiligo causes patches of skin to lose their colour. The main aim is to find out if taking 15mg pioglitazone tablets helps to bring back colour to at least 50% of the affected skin over 16 weeks, and whether it's safe and well-tolerated. This is an early stage (Phase 2) study, meaning we are exploring the medicine's potential benefits and side effects for this specific condition in a group of people. Participants will be adults aged 18 and over.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

I.F.O. Istituti Fisioterapici Ospitalieri

Enrolment target

Start

26 Nov 2025

Vitiligo

What is this study about?

This research study is called 'A phase 2 multi-center study investigating the efficacy, safety and tolerability of pioglitazone in adult participants with non-segmental vitiligo'. Let's break that down. 'Vitiligo' is a condition where your skin loses its natural colour, creating pale or white patches. 'Non-segmental vitiligo' means these patches can appear in different areas all over your body.

We are looking at a medicine called pioglitazone. This medicine is already approved and used for other health conditions, but we want to see if it could also help people with vitiligo. This type of study, called a 'Phase 2' study, is designed to explore if the medicine works for this new condition, how well it works, what the right dose might be, and to check its safety and how well people tolerate it.

The main goal is to see if taking 15mg pioglitazone tablets for 16 weeks can lead to a significant improvement in skin colour for people with vitiligo. Specifically, we want to know if at least 50% of the affected skin regains its colour. This study is important because finding new ways to manage vitiligo could greatly improve the lives of those affected.

Key takeaways

A study testing pioglitazone (an existing medicine) for vitiligo.
Aims to see if it improves skin colour and is safe.
Participants will take 15mg tablets for 16 weeks.
For adults aged 18 and over with non-segmental vitiligo.
This is an early-stage (Phase 2) research study.

Who may be eligible?

To be able to take part in this study, you must be an adult, meaning you are 18 years old or older. There is no upper age limit for joining.

Both men and women can take part in this research study. The study is open to anyone who meets the other specific health requirements for vitiligo research, which would be explained in more detail by the study team.

In simple terms, if you're an adult with non-segmental vitiligo, you might be suitable. Your doctor will carefully check if you meet all the detailed criteria to ensure the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have non-segmental vitiligo?
Are you generally in good health apart from your vitiligo?
Are you able to attend regular clinic visits?
Are you willing to take study medication as directed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given pioglitazone tablets to take regularly over 16 weeks. You would have several visits to the study clinic during this time to check on your progress and make sure you are well. At these visits, the study team would examine your skin to measure any changes in your vitiligo. They would also take blood and urine samples and ask you questions about your general health and how you are feeling. There would likely be a follow-up period after the 16 weeks of treatment to see how you are doing. The total duration of your involvement, including initial checks, treatment, and follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in this study could potentially offer a benefit if pioglitazone helps to improve your vitiligo, although this is not guaranteed for everyone. You would also be contributing to important medical research that could help others in the future. However, like all medicines, pioglitazone can have side effects, and some are known. The study team will explain all known or potential risks in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is vitiligo?

Vitiligo is a skin condition where patches of skin lose their natural pigment, turning white. It's not infectious and doesn't usually cause physical discomfort, but it can affect how people feel about their appearance.

What is pioglitazone?

Pioglitazone is a medicine that's currently used to help manage type 2 diabetes by improving how the body uses insulin. In this study, we're exploring if it might have benefits for vitiligo.

What does 'Phase 2 study' mean?

A Phase 2 study is an early stage of clinical research. It's designed to see if a new treatment works for a specific condition, to find the right dose, and to further check its safety in a small group of people.

How long would I need to take the medicine for?

If you join the study, you would be taking the pioglitazone tablets for 16 weeks as part of the treatment plan.

Will I definitely get the active medicine?

Clinical trials are often designed so that some participants receive the active medicine and others receive a placebo (a dummy pill) or another standard treatment. The study team will explain the details of this particular trial design.