NonSegmental Vitiligo, Nonsegmental Vitiligo (Stable)
Conditions
Keywords
Melanotan II, MT-II, melanocortin receptor agonist, MC1R, melanogenesis, skin pigmentation, repigmentation, vitiligo, narrowband UV-B, phototherapy
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.
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.
Interventions
DRUGMelanotan II (MT-II)
administered per protocol
DRUGPlacebo
matched, administered per protocol.
PROCEDURENarrowband UV-B (NB-UVB) phototherapy
standardized schedule per site protocol
Sponsors
Hudson Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants are randomized 1:1 to investigational Melanotan II or matching placebo while receiving standardized NB-UVB phototherapy for 24 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Vitiligo Area Scoring Index (VASI) total score | 24 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving | 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 |
Countries
China
Contacts
CONTACTSeni S Lu, Phd
Outcome results
None listed