VitiligoPhase 3NCT07682506
A Phase III Clinical Study to Evaluate the Efficacy and Safety of MH004 Ointment in Non-segmental Vitiligo
A Phase 3 study testing MH004 1.0% Ointment in people with Vitiligo, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- MH004 1.0% Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2026to 4 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Women of Childbearing Potential (WOCBP) and male participants whose partners are WOCBP must agree to use reliable contraceptive methods throughout the trial period and for 28 days after the last study drug administration (abstinence, prior sterilization, oral contraceptives, and/or barrier methods [condoms, diaphragms, cervical caps, etc.]). For WOCBP, the human chorionic gonadotropin (hCG) pregnancy test result at the screening visit and prior to the first drug administration at the baseline visit must be negative. Male participants shall not donate sperm during the trial and for 3 months after study completion or drug discontinuation.
- The participant and/or their legal guardian shall fully understand the trial content, requirements and procedures, voluntarily participate in this clinical trial and sign the ICF, and be willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other study procedures throughout the trial.
Who cannot join
- 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.).
- Specific prior treatment history:
- Prior use of any JAK inhibitor (systemic or topical) for vitiligo treatment at any time;
Show all 32Show fewer
- Prior depigmentation therapy for vitiligo (e.g., monobenzone), excluding hydroquinone;
- Prior melanocyte-keratinocyte transplantation or other surgical procedures for vitiligo on the face.
- Treatments administered within the required washout period
- Use of biologic agents within 12 weeks or 5 half-lives (whichever is longer) prior to the first study drug administration;
- Receipt of laser therapy or any form of phototherapy (including tanning beds) within 8 weeks prior to the first study drug administration;
- Within 4 weeks prior to the first study drug administration:
- Systemic immunomodulators (e.g., corticosteroids, methotrexate, cyclosporine, etc.); Systemic medications that may affect vitiligo (e.g., melanocyte-stimulating agents, tetracyclines, methoxsalen, etc.); Administration of live or live-attenuated vaccines;
- Oral traditional Chinese medicines for vitiligo within 2 weeks prior to the first study drug administration;
- Topical agents applied to vitiligo lesions within 1 week prior to the first study drug administration (e.g., corticosteroids, calcineurin inhibitors, PDE4 inhibitors, retinoids, vitamin D3 analogues, or topical Chinese herbal preparations);
- Temporary tattoos within vitiligo lesions within 30 days before the first dose (excluding vinyl adhesive tattoos), or any permanent tattoos previously placed within vitiligo lesions.
- Concomitant diseases or medical history that may interfere with the study
- Specific risks of cardiovascular and thromboembolic events
- Active or latent infections
- Positive virology screening results at screening
- History of malignancy
- Clinically significant abnormal laboratory values
- Subjects planning major invasive procedures during the study, or with prior or planned organ transplantation requiring long-term immunosuppressants (e.g., kidney or liver transplantation).
- Planned administration of live or live-attenuated vaccines during the study period.
- Female subjects who are pregnant or breastfeeding.
- Participation in another interventional drug clinical trial within 3 months or at least 5 half-lives (whichever is longer) prior to randomization; or participation in a medical device clinical trial within 3 months prior to randomization.
- Hypersensitivity and intolerance Known hypersensitivity to the investigational product or any excipient components.
- Other exclusion factors
- History of alcohol abuse or substance misuse;
- Subjects shall avoid intentional excessive sun exposure during the study (e.g., prolonged sunbathing, sun exposure for tanning purposes);
- Body mass index (BMI) < 16 kg/m² or > 40 kg/m², where BMI = weight (kg) / height² (m²);
- Any other conditions deemed inappropriate for study participation by the Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Ethics Committee, +86 010 88324516, rmyyllwyh@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of MH004 Ointment in Adolescent and Adult Subjects With Non-segmental Vitiligo
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.
Read the detailed description
The study consists of a screening period, a treatment period and a follow-up period, with the treatment period divided into two phases. In Double-blind Treatment Phase (24 weeks, D1 to W24), participants will be randomized at a 2:1 ratio to receive either MH004 ointment or placebo. And in Extended Treatment Phase (28 weeks, W25 to W52), after all participants complete all assessments prior to dosing at W24, they will enter the extended treatment phase and receive 1.0% MH004 ointment with the same dosing regimen as that in the double-blind treatment phase, administered twice daily (BID) until W52. Upon completion of study treatment, all participants will enter a 4-week safety follow-up period. The primary objective of this trial is the proportion of participants achieving at least a 75% improvement from baseline in the Facial Vitiligo Area Scoring Index at Week 24 (F-VASI75).
- Conditions
- Vitiligo
- Being tested
- MH004 1.0% Ointment, MH004 Placebo Ointment
- Keywords
- vitiligo, NSV, MH004
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MH004 1.0% OintmentDrug
MH004 1% ointment applied topically to the affected area as a thin film twice a day (BID).
MH004 Placebo OintmentDrug
MH004 Placebo ointment applied topically to the affected area as a thin film twice a day (BID).
| Study group | Role | What they receive |
|---|---|---|
| Double-Masked Period: MH004 1.0% Ointment | Experimental | Participants received MH004 1.0% Ointment topically twice a day (BID) from Day 1 to Week 24 during the Double-Masked Period. Receives: Drug: MH004 1.0% Ointment |
| Double-Masked Period: MH004 Placebo | Placebo comparator | Participants received MH004 Placebo Ointment topically twice a day (BID) from Day 1 to Week 24 during the Double-Masked Period. Receives: Drug: MH004 Placebo Ointment |
| Extended Treatment Period: MH004 1.0% Ointment | Experimental | Participants received MH004 1.0%Ointment twice a day (BID) from Week 25 to Week 52 during the Extended Treatment Period. Receives: Drug: MH004 1.0% Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline; Week 24
Secondary outcomes (21)
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).
Measured: Baseline; Week 24
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).
Measured: Baseline; Week 24
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).
Measured: Baseline; Week 24
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).
Measured: Baseline; Week 24
Proportion of participants achieving at least a 90% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI90) at Week 24 (W24)
A T-VASI90 responder achieved at least 90% 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).
Measured: Baseline; Week 24
Proportion of participants achieving F-VASI75 at Week 52 (W52)
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).
Measured: Baseline; Week 52
Proportion of participants achieving T-VASI75 at Week 52 (W52)
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).
Measured: Basline; Week 52
Percentage change from baseline in F-VASI score at Week 24
F-VASI was measured by the percentage of vitiligo involvement (percentage of 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). Percentage change = ([post-BL value minus BL value]/BL value) X 100.
Measured: Baseline; Week 24
Percentage change from baseline in F-VASI score at Week 52
F-VASI was measured by the percentage of vitiligo involvement (percentage of 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). Percentage change = ([post-BL value minus BL value]/BL value) X 100.
Measured: Baseline; Week 52
Percentage change from baseline in T-VASI score at Week 24
T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to 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). Percentage change = ([post-BL value minus BL value]/BL value) X 100.
Measured: Baseline; Week 24
Percentage change from baseline in T-VASI score at Week 52
T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to 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). Percentage change = ([post-BL value minus BL value]/BL value) X 100.
Measured: Baseline; Week 52
Percentage change from baseline in facial body surface area (F-BSA) score at Week 24 (W24)
F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline (BL) value minus BL value]/BL value) X 100.
Measured: Baseline; Week 24
Percentage change from baseline in total body surface area (T-BSA) score at Week 24 (W24)
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100.
Measured: Baseline; Week 24
Proportion of participants achieving F-VASI50 at Week 52 (W52)
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).
Measured: Baseline; Week 52
Proportion of participants achieving F-VASI90 at Week 52 (W52)
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).
Measured: Baseline; Week 52
Proportion of participants achieving T-VASI50 at Week 52 (W52)
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).
Measured: Basline; Week 52
Proportion of participants achieving T-VASI90 at Week 52 (W52)
A T-VASI90 responder achieved at least 90% 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).
Measured: Basline; Week 52
Percentage change from baseline in facial body surface area (F-BSA) score at Week 52 (W52)
F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline (BL) value minus BL value]/BL value) X 100.
Measured: Baseline; Week 52
Percentage change from baseline in total body surface area (T-BSA) score at Week 52 (W52)
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100.
Measured: Baseline; Week 52
Incidence, Frequency, Duration and Severity of Treatment-Emergent Adverse Event (TEAE)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Measured: From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 56)
Incidence of Treatment-Emergent Serious Adverse Event (SAE) and Incidence of AEs resulting discontinue medication
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Measured: From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start4 Aug 2026
- Primary completion23 Feb 2028 (estimated)
- Study completion4 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682506
- Sponsor's protocol ID
- MH004-P-303
- Status last verified
- Aug 2026
- First submitted
- 28 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of MH004 Ointment in Adolescent and Adult Subjects With Non-segmental Vitiligo
- ClinicalTrials.gov ID
- NCT07682506
- Acronym / sponsor ID
- MH004-P-303
- Conditions
- Vitiligo
- Keywords
- vitiligo, NSV, MH004
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 23 Feb 2028 (estimated)
- Study completion
- 4 Oct 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study consists of a screening period, a treatment period and a follow-up period, with the treatment period divided into two phases. In Double-blind Treatment Phase (24 weeks, D1 to W24), participants will be randomized at a 2:1 ratio to receive either MH004 ointment or placebo. And in Extended Treatment Phase (28 weeks, W25 to W52), after all participants complete all assessments prior to dosing at W24, they will enter the extended treatment phase and receive 1.0% MH004 ointment with the same dosing regimen as that in the double-blind treatment phase, administered twice daily (BID) until W52. Upon completion of study treatment, all participants will enter a 4-week safety follow-up period. The primary objective of this trial is the proportion of participants achieving at least a 75% improvement from baseline in the Facial Vitiligo Area Scoring Index at Week 24 (F-VASI75).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double-Masked Period: MH004 1.0% Ointment | Experimental | Drug: MH004 1.0% OintmentParticipants received MH004 1.0% Ointment topically twice a day (BID) from Day 1 to Week 24 during the Double-Masked Period. |
| Double-Masked Period: MH004 Placebo | Placebo comparator | Drug: MH004 Placebo OintmentParticipants received MH004 Placebo Ointment topically twice a day (BID) from Day 1 to Week 24 during the Double-Masked Period. |
| Extended Treatment Period: MH004 1.0% Ointment | Experimental | Drug: MH004 1.0% OintmentParticipants received MH004 1.0%Ointment twice a day (BID) from Week 25 to Week 52 during the Extended Treatment Period. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Women of Childbearing Potential (WOCBP) and male participants whose partners are WOCBP must agree to use reliable contraceptive methods throughout the trial period and for 28 days after the last study drug administration (abstinence, prior sterilization, oral contraceptives, and/or barrier methods [condoms, diaphragms, cervical caps, etc.]). For WOCBP, the human chorionic gonadotropin (hCG) pregnancy test result at the screening visit and prior to the first drug administration at the baseline visit must be negative. Male participants shall not donate sperm during the trial and for 3 months after study completion or drug discontinuation.
Key exclusion criteria (32 listed)
- All terminal hairs (i.e., beard, eyebrows, eyelashes) within facial vitiligo areas are depigmented white.
- Other subtypes of vitiligo or hypopigmentary disorders
- Specific prior treatment history:
- Treatments administered within the required washout period
- Systemic immunomodulators (e.g., corticosteroids, methotrexate, cyclosporine, etc.); Systemic medications that may affect vitiligo (e.g., melanocyte-stimulating agents, tetracyclines, methoxsalen, etc.); Administration of live or live-attenuated vaccines;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MH004 1.0% OintmentMH004 1% ointment applied topically to the affected area as a thin film twice a day (BID). | Drug | Double-Masked Period: MH004 1.0% Ointment, Extended Treatment Period: MH004 1.0% Ointment |
| MH004 Placebo OintmentMH004 Placebo ointment applied topically to the affected area as a thin film twice a day (BID). | Drug | Double-Masked Period: MH004 Placebo |
Primary outcome
Proportion of participants achieving at least a 75% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI75) at Week 24 (W24)
Time frame: Baseline; Week 24
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).
21 secondary outcomes
Proportion of participants achieving at least a 50% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI50) at Week 24 (W24)
Time frame: Baseline; Week 24
Proportion of participants achieving at least a 90% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI90) at Week 24 (W24)
Time frame: Baseline; Week 24
Proportion of participants achieving at least a 50% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI50) at Week 24 (W24)
Time frame: Baseline; Week 24
Proportion of participants achieving at least a 75% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI75) at Week 24 (W24)
Time frame: Baseline; Week 24
Proportion of participants achieving at least a 90% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI90) at Week 24 (W24)
Time frame: Baseline; Week 24
Proportion of participants achieving F-VASI75 at Week 52 (W52)
Time frame: Baseline; Week 52
Proportion of participants achieving T-VASI75 at Week 52 (W52)
Time frame: Basline; Week 52
Percentage change from baseline in F-VASI score at Week 24
Time frame: Baseline; Week 24
Percentage change from baseline in F-VASI score at Week 52
Time frame: Baseline; Week 52
Percentage change from baseline in T-VASI score at Week 24
Time frame: Baseline; Week 24
Percentage change from baseline in T-VASI score at Week 52
Time frame: Baseline; Week 52
Percentage change from baseline in facial body surface area (F-BSA) score at Week 24 (W24)
Time frame: Baseline; Week 24
Percentage change from baseline in total body surface area (T-BSA) score at Week 24 (W24)
Time frame: Baseline; Week 24
Proportion of participants achieving F-VASI50 at Week 52 (W52)
Time frame: Baseline; Week 52
Proportion of participants achieving F-VASI90 at Week 52 (W52)
Time frame: Baseline; Week 52
Proportion of participants achieving T-VASI50 at Week 52 (W52)
Time frame: Basline; Week 52
Proportion of participants achieving T-VASI90 at Week 52 (W52)
Time frame: Basline; Week 52
Percentage change from baseline in facial body surface area (F-BSA) score at Week 52 (W52)
Time frame: Baseline; Week 52
Percentage change from baseline in total body surface area (T-BSA) score at Week 52 (W52)
Time frame: Baseline; Week 52
Incidence, Frequency, Duration and Severity of Treatment-Emergent Adverse Event (TEAE)
Time frame: From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 56)
Incidence of Treatment-Emergent Serious Adverse Event (SAE) and Incidence of AEs resulting discontinue medication
Time frame: From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 56)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Vitiligo
Active, not recruiting
Plasma Exeresis Plus NB-UVB Versus NB-UVB Alone for Stable Vitiligo
Vitiligo
RecruitingPhase 3
Evaluation of Crisaborole 2% Versus Tacrolimus 0.1% Each Combined With Excimer Light in the Treatment of Stable Non-segmental Facial Vitiligo: a Prospective Randomized Controlled Study.
Vitiligo, Non-Segmental Vitiligo (NSV)
RecruitingPhase 1
A Trial to Test the Safety and Efficacy of TEV-53408 in Participants With Vitiligo
Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
Not yet recruitingPhase 3
A Study to Learn How Effective, Safe, and Tolerable Upadacitinib is for Young Participants With Non-segmental Vitiligo
Non-Segmental Vitiligo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MH004 1.0% Ointment in people with Vitiligo, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CMO/ Senior Vice President of R&D (+ 86 0571-86963293, jwshi@minghuipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving at least a 75% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI75) at Week 24 (W24) (time frame: Baseline; Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.