Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHudson Biotech
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Melanotan II (MT-II)
Drugadministered per protocol
Placebo
Drugmatched, administered per protocol.
Narrowband UV-B (NB-UVB) phototherapy
Procedure/Surgerystandardized schedule per site protocol
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Melanotan II + NB-UVB phototherapyExperimental treatment 3 interventions
Group B: Placebo + NB-UVB phototherapyPlacebo comparator 3 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in Vitiligo Area Scoring Index (VASI) total score
Time frame
24 WeeksSecondary 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
Time frame
24 WeeksSponsors and contacts
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Source ClinicalTrials.gov