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
Qualifiers
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
Treatments tested in this trial
- Melanotan II (MT-II)
- Placebo
- Narrowband UV-B (NB-UVB) phototherapy
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov