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New treatment option for NonSegmental Vitiligo
Official title Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo
ClinicalTrials.gov ID: NCT07437560
What this study is testing
What is Melanotan II (MT-II)?
Melanotan II (MT-II) is an investigational medicine, being studied as a potential treatment for nonsegmental vitiligo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This example interventional study record describes a randomized Phase 2 clinical trial evaluating investigational Melanotan II (MT-II) as an adjunct to standard NB-UVB phototherapy for repigmentation in adults with stable nonsegmental vitiligo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adults aged 18-65 years able to provide informed consent.
- Clinical diagnosis of nonsegmental vitiligo with stable disease (no new lesions and no lesion expansion) for \>=6 months prior to screening.
- Total body surface area involvement between 3% and 20% (inclusive), with at least two measurable target lesions suitable for standardized photography...
- Willingness to undergo NB-UVB phototherapy per protocol and to avoid non-study vitiligo treatments during the study.
- For participants of childbearing potential: agreement to use effective contraception during the study and for a protocol-specified period after the...
You likely can't join if
- Segmental vitiligo as the predominant type, or rapidly progressive disease within the past 6 months.
- Use of systemic immunosuppressive therapy, systemic corticosteroids, or JAK inhibitors within 8 weeks prior to screening (time windows may vary by...
- Use of topical calcineurin inhibitors or topical corticosteroids on target lesions within 2 weeks prior to baseline.
- Prior treatment with afamelanotide or melanotan (including Melanotan II) within 6 months prior to baseline.
- History of melanoma, dysplastic nevus syndrome, or other high-risk skin cancer history requiring close surveillance, as judged by the investigator.
- Clinically significant uncontrolled hypertension, cardiovascular disease, or any condition that, in the investigator's judgment, increases risk with...
See the full eligibility criteria
- Adults aged 18-65 years able to provide informed consent.
- Clinical diagnosis of nonsegmental vitiligo with stable disease (no new lesions and no lesion expansion) for \>=6 months prior to screening.
- Total body surface area involvement between 3% and 20% (inclusive), with at least two measurable target lesions suitable for standardized photography and colorimetry.
- Willingness to undergo NB-UVB phototherapy per protocol and to avoid non-study vitiligo treatments during the study.
- For participants of childbearing potential: agreement to use effective contraception during the study and for a protocol-specified period after the last dose.
- Segmental vitiligo as the predominant type, or rapidly progressive disease within the past 6 months.
- Use of systemic immunosuppressive therapy, systemic corticosteroids, or JAK inhibitors within 8 weeks prior to screening (time windows may vary by drug/class).
- Use of topical calcineurin inhibitors or topical corticosteroids on target lesions within 2 weeks prior to baseline.
- Prior treatment with afamelanotide or melanotan (including Melanotan II) within 6 months prior to baseline.
- History of melanoma, dysplastic nevus syndrome, or other high-risk skin cancer history requiring close surveillance, as judged by the investigator.
- Clinically significant uncontrolled hypertension, cardiovascular disease, or any condition that, in the investigator's judgment, increases risk with melanocortin agonist exposure.
- Pregnant or breastfeeding.
- Known hypersensitivity to study product components.
- Participation in another treatment clinical trial within 30 days prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.