Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melanotan II (MT-II), Placebo, Narrowband UV-B (NB-UVB) phototherapy.
- Who it may be relevant to
- Registry conditions: NonSegmental Vitiligo, Nonsegmental Vitiligo (Stable). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Melanotan II (Synthetic Cyclic Melanocortin Receptor Agonist) as an Adjunct to Narrowband UV-B Phototherapy in Adults With Stable Nonsegmental Vitiligo
Overview
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.
Detailed description
Vitiligo is characterized by acquired depigmented macules and patches due to the loss of functional melanocytes. Narrowband UV-B (NB-UVB) phototherapy is a common treatment that can promote repigmentation, but responses may be incomplete and can take months. Melanotan II (MT-II) is a synthetic cyclic melanocortin receptor agonist with activity at melanocortin receptors involved in melanogenesis (pigment production). This example trial evaluates the safety and preliminary efficacy of adding investigational MT-II to standardized NB-UVB phototherapy compared with placebo plus NB-UVB in adults with stable nonsegmental vitiligo. Participants are randomized 1:1 and treated for 24 weeks, with standardized digital photography, clinician-rated scoring, and objective colorimetry performed at prespecified visits. Safety monitoring includes adverse event collection, vital signs, and focused skin examinations (including monitoring of nevi). A follow-up visit occurs 4 weeks after the final dose to assess ongoing safety.
Interventions
- Drug Melanotan II (MT-II)
administered per protocol - Drug Placebo
matched, administered per protocol. - Procedure Narrowband UV-B (NB-UVB) phototherapy
standardized schedule per site protocol
Primary outcome measures
- Change from baseline in Vitiligo Area Scoring Index (VASI) total score [Time frame: 24 Weeks]
Secondary outcome measures (1)
- Proportion of participants achieving [Time frame: 24 Weeks]
Eligibility criteria
Inclusion 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.
Exclusion criteria
- 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 interventional clinical trial within 30 days prior to screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Shenzhen Hospital — Shenzhen
Identifiers
NCT: NCT07437560 · DERM-MTII-201