NCT07437560

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
21mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026Feb 2028

Study Start

First participant enrolled

February 2, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 22, 2026

Last Update Submit

February 22, 2026

Conditions

NonSegmental VitiligoNonsegmental Vitiligo (Stable)

Keywords

Melanotan IIMT-IImelanocortin receptor agonistMC1Rmelanogenesisskin pigmentationrepigmentationvitiligonarrowband UV-Bphototherapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Vitiligo Area Scoring Index (VASI) total score

    24 Weeks

Secondary Outcomes (1)

  • Proportion of participants achieving

    24 Weeks

Study Arms (2)

Melanotan II + NB-UVB phototherapy

EXPERIMENTAL
Drug: Melanotan II (MT-II)Drug: PlaceboProcedure: Narrowband UV-B (NB-UVB) phototherapy

Placebo + NB-UVB phototherapy

PLACEBO COMPARATOR
Drug: Melanotan II (MT-II)Drug: PlaceboProcedure: Narrowband UV-B (NB-UVB) phototherapy

Interventions

Melanotan II (MT-II)DRUG

administered per protocol

Melanotan II + NB-UVB phototherapyPlacebo + NB-UVB phototherapy
PlaceboDRUG

matched, administered per protocol.

Melanotan II + NB-UVB phototherapyPlacebo + NB-UVB phototherapy
Narrowband UV-B (NB-UVB) phototherapyPROCEDURE

standardized schedule per site protocol

Melanotan II + NB-UVB phototherapyPlacebo + NB-UVB phototherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

MeSH Terms

Conditions

Pigmentation DisordersVitiligo

Interventions

melanotan-IIPhototherapy

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHypopigmentation

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Seni S Lu, Phd

CONTACT

+86 13076790030Seni-Lu@beijing-biotech.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigational product and placebo are identical in appearance and packaging. Randomization codes are held by an unblinded pharmacist/third party. Outcome assessments are performed by blinded evaluators using standardized photographs and scoring rules.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized 1:1 to investigational Melanotan II or matching placebo while receiving standardized NB-UVB phototherapy for 24 weeks.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

February 14, 2027

Study Completion (Estimated)

February 17, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

CN(1)