NonSegmental VitiligoPhase 2MTII-VITNCT07437560
Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo
A Phase 2 study testing Melanotan II (MT-II) and Narrowband UV-B (NB-UVB) phototherapy in people with NonSegmental Vitiligo and Nonsegmental Vitiligo (Stable), run by Hudson Biotech at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NonSegmental Vitiligo, Nonsegmental Vitiligo (Stable)
- What is being tested?
- Melanotan II (MT-II) and Narrowband UV-B (NB-UVB) phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 17 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnant or breastfeeding.
- Known hypersensitivity to study product components.
- Participation in another interventional clinical trial within 30 days prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
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
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.
Read the 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.
- Being tested
- Melanotan II (MT-II), Placebo, Narrowband UV-B (NB-UVB) phototherapy
- Keywords
- Melanotan II, MT-II, melanocortin receptor agonist, MC1R, melanogenesis, skin pigmentation, repigmentation, vitiligo, narrowband UV-B, phototherapy
- Medical subject headings
- Pigmentation Disorders, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanotan II (MT-II)Drug
administered per protocol
PlaceboDrug
matched, administered per protocol.
Narrowband UV-B (NB-UVB) phototherapyProcedure or surgery
standardized schedule per site protocol
| Study group | Role | What they receive |
|---|---|---|
| Melanotan II + NB-UVB phototherapy | Experimental | Not described Receives: Drug: Melanotan II (MT-II); Drug: Placebo; Procedure: Narrowband UV-B (NB-UVB) phototherapy |
| Placebo + NB-UVB phototherapy | Placebo comparator | Not described Receives: Drug: Melanotan II (MT-II); Drug: Placebo; Procedure: Narrowband UV-B (NB-UVB) phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Vitiligo Area Scoring Index (VASI) total score
Measured: 24 Weeks
Secondary outcomes (1)
Proportion of participants achieving
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
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Feb 2026
- Primary completion14 Feb 2027 (estimated)
- Study completion17 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NonSegmental VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to investigational Melanotan II or matching placebo while receiving standardized NB-UVB phototherapy for 24 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hudson Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437560
- Sponsor's protocol ID
- DERM-MTII-201
- Acronym
- MTII-VIT
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07437560
- Acronym / sponsor ID
- MTII-VIT / DERM-MTII-201
- Keywords
- Melanotan II, MT-II, melanocortin receptor agonist, MC1R, melanogenesis, skin pigmentation, repigmentation, vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hudson BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 17 Feb 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to investigational Melanotan II or matching placebo while receiving standardized NB-UVB phototherapy for 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Melanotan II + NB-UVB phototherapy | Experimental | Drug: Melanotan II (MT-II), Drug: Placebo, Procedure: Narrowband UV-B (NB-UVB) phototherapy |
| Placebo + NB-UVB phototherapy | Placebo comparator | Drug: Melanotan II (MT-II), Drug: Placebo, Procedure: Narrowband UV-B (NB-UVB) phototherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melanotan II (MT-II)administered per protocol | Drug | Melanotan II + NB-UVB phototherapy, Placebo + NB-UVB phototherapy |
| Placebomatched, administered per protocol. | Drug | Melanotan II + NB-UVB phototherapy, Placebo + NB-UVB phototherapy |
| Narrowband UV-B (NB-UVB) phototherapystandardized schedule per site protocol | Procedure or surgery | Melanotan II + NB-UVB phototherapy, Placebo + NB-UVB phototherapy |
Primary outcome
Change from baseline in Vitiligo Area Scoring Index (VASI) total score
Time frame: 24 Weeks
1 secondary outcome
Proportion of participants achieving
Time frame: 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melanotan II (MT-II) and Narrowband UV-B (NB-UVB) phototherapy in people with NonSegmental Vitiligo and Nonsegmental Vitiligo (Stable), run by Hudson Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seni S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Vitiligo Area Scoring Index (VASI) total score (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.