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Study on Pioglitazone for Adults with Non-Segmental 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 clinical trial is focused on studying the effects of a medication called Pioglitazone on a skin condition known as non-segmental vitiligo. Non-segmental vitiligo is a condition where patches of skin lose their color, leading to white spots on various parts of the body. The study aims to understand how effective and safe Pioglitazone is when used alongside a type of light therapy called NB-UVB, compared to using the light therapy alone.

Participants in the study will be adults who have active non-segmental vitiligo. The study will last for a period of 32 weeks. During this time, participants will receive either the combination of Pioglitazone and NB-UVB or just NB-UVB treatment. The goal is to see if there is at least a 50% improvement in the skin condition by the end of the study. Participants will also be asked to assess their own quality of life related to their skin condition throughout the study.

The study will help determine if adding Pioglitazone to the existing light therapy can provide better results for people with non-segmental vitiligo. This information could be valuable for developing more effective treatment options for this condition in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide a personally signed and dated informed consent document. This document confirms that you have been informed of all important aspects of the study.
You must be an adult between 18 and 65 years old and have a clinical diagnosis of non-segmental vitiligo for at least 6 months. The affected area should cover at least 0.5% of your face, confirmed by photographs.
Step 2
Medication administration
You will be administered Pioglitazone Morningside 15mg Tablets orally. The specific dosage, frequency, and duration of administration will be provided by the study team.
Step 3
Treatment period
The main objective of the study is to evaluate the effectiveness of Pioglitazone in combination with NB-UVB light therapy compared to NB-UVB therapy alone. This will be measured through various clinical assessments over time.
The study will monitor your progress and any changes in your condition, including improvements in the Vitiligo Area Scoring Index (VASI) and quality of life assessments.
Step 4
Evaluation and follow-up
The primary endpoint of the study is to determine the proportion of participants achieving a 50% improvement in VASI from the start of the study by week 32.
Your progress will be evaluated at designated time points, and changes in your vitiligo condition and quality of life will be assessed.

Who can join the trial?

9 criteria

You must be an adult between 18 and 65 years old.
You can be of any gender.
You must have a clinical diagnosis of non-segmental vitiligo for at least 6 months.
You must have at least 0.5% of your face affected by vitiligo, confirmed by photographs.
If you are a female who can become pregnant, you must agree to use one method of birth control during the study and for at least 30 days after the last treatment.
If you are a female who cannot become pregnant, you must meet one of the following conditions:
- You have not had a period for at least 12 months for reasons other than medical conditions, which may be confirmed by a blood test.
- You have had surgery to remove your uterus or both ovaries.
- You have a medical confirmation of ovarian failure.
- You must provide a signed and dated consent form indicating that you understand the study details.

Who cannot join the trial?

7 criteria

Patients who have any other skin conditions that might interfere with the study.
Patients who are currently using any treatments that could affect the study results.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with any serious medical conditions that could affect their safety or the study results.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

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Verified
I.F.O. Istituti Fisioterapici Ospitalieri
Rome, Italy

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Investigated drugs

Pioglitazone
is a medication that is being studied for its potential to help treat non-segmental vitiligo, a condition where patches of skin lose their color. In this trial, researchers are looking at how well pioglitazone works when used together with another therapy called NB-UVB. Pioglitazone is usually used to help control blood sugar levels in people with type 2 diabetes, but in this study, it is being tested to see if it can also help improve skin color in people with vitiligo.
NB-UVB
stands for Narrowband Ultraviolet B therapy. It is a type of light treatment that is commonly used to treat skin conditions like vitiligo. In this trial, NB-UVB is used alone and in combination with pioglitazone to see if the combination is more effective than NB-UVB by itself. The therapy involves exposing the skin to a specific type of ultraviolet light, which can help restore skin color in people with vitiligo.

Pioglitazone

What is already known about the treatment

Pioglitazone – Pioglitazone is administered orally in the form of a tablet. It is currently being studied in clinical trials for its potential use in treating non-segmental vitiligo, a condition characterized by the loss of skin color in patches. The main therapeutic indication being investigated is its ability to improve skin pigmentation when used alongside narrowband ultraviolet B (NB-UVB) therapy. At the molecular level, pioglitazone works by activating a specific receptor in the body that helps regulate genes involved in glucose and lipid metabolism, which may also influence skin cell function. It is classified pharmacologically as a thiazolidinedione, a type of medication commonly used to manage blood sugar levels in diabetes.

Investigated diseases

Non-segmental vitiligo – Non-segmental vitiligo is a skin condition characterized by the loss of pigment, resulting in white patches on the skin. It occurs when the cells responsible for skin pigmentation, called melanocytes, are destroyed. This type of vitiligo is the most common form and can affect any part of the body, often symmetrically. The progression of non-segmental vitiligo is unpredictable, with periods of stability and times when new patches appear. The condition can spread over time, affecting larger areas of the skin. It is not associated with physical discomfort but can have psychological and social impacts.