Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo (MTII-VIT)

February 22, 2026 updated by: Hudson Biotech

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melanotan II + NB-UVB phototherapy
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
Placebo Comparator: Placebo + NB-UVB phototherapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Vitiligo Area Scoring Index (VASI) total score
Time Frame: 24 Weeks
24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving
Time Frame: 24 Weeks
50% improvement in VASI (VASI50). 2) Time to first clinically detectable repigmentation in target lesions (standardized photography). 3) Change from baseline in objective pigmentation (melanin index) in predefined target lesions (colorimetry). 4) Change from baseline in Dermatology Life Quality Index (DLQI). 5) Incidence and severity of adverse events (AEs) and clinically significant dermatologic changes
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hudson Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Estimated)

February 14, 2027

Study Completion (Estimated)

February 17, 2028

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DERM-MTII-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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