This is a randomized, double-blind, multicenter, placebo-controlled clinical study intended to evaluate the efficacy, safety and population pharmacokinetic profiles of MH004 ointment in eligible participants with NSV.
Subjects aged 12 to 75 years inclusive at the time of signing the Informed Consent Form (ICF), with no restriction on gender.
Clinically diagnosed with non-segmental vitiligo.
Prior to study drug administration, participants with vitiligo shall meet the following criteria regarding vitiligo lesion area: Facial lesion area ≥ 0.3% body surface area (BSA), and Facial Vitiligo Area Scoring Index (F-VASI) score ≥ 0.3.
Agree to discontinue all vitiligo therapeutic medications and interventions from the time of ICF signature until the end of the last study visit. Over-the-counter (OTC) drugs shall not exert therapeutic effects on vitiligo or interfere with skin pigmentation, including corticosteroids and other immunomodulators. Final eligibility of such OTC drugs shall be determined by the Investigator. Camouflaging makeup is permitted.
All terminal hairs (i.e., beard, eyebrows, eyelashes) within facial vitiligo areas are depigmented white.
Other subtypes of vitiligo or hypopigmentary disorders
Segmental vitiligo, unclassified vitiligo, or mixed vitiligo;
Other differential diagnoses of vitiligo or other cutaneous hypopigmentary diseases (e.g., piebaldism, pityriasis alba, nevus anemicus, post-inflammatory hypopigmentation, chemical leukoderma, tinea versicolor, etc.).
Parallel
MH004 1.0% Ointment
DrugMH004 1% ointment applied topically to the affected area as a thin film twice a day (BID).
MH004 Placebo Ointment
DrugMH004 Placebo ointment applied topically to the affected area as a thin film twice a day (BID).
Proportion of participants achieving at least a 75% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI75) at Week 24 (W24)
An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment).
Proportion of participants achieving at least a 50% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI50) at Week 24 (W24)
An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Proportion of participants achieving at least a 90% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI90) at Week 24 (W24)
An F-VASI90 responder achieved at least 90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment).
Proportion of participants achieving at least a 50% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI50) at Week 24 (W24)
A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).
Proportion of participants achieving at least a 75% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI75) at Week 24 (W24)
A T-VASI75 responder achieved at least 75% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present).
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