VitiligoPhase 2NCT07181187
Phase II Clinical Trial of MH004 Ointment in Patients With Non-segmental Vitiligo
A Phase 2 study testing MH004 Ointment in people with Vitiligo, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, vehicle-controlled phase II study of MH004 Ointment with a 28-week open-label long-term safety extension period. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and primary efficacy of MH004 Ointment in adolescents and adults with… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- MH004 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2024to 7 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 12 to 65 years (inclusive) of either gender.
- Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face and total body vitiligo area not exceeding 20% BSA.
- Fully understand the trial content, voluntarily participate in the trial, and sign the ICF.
- Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.
- -
Who cannot join
- Other dermatoses that may complicate the assessment of vitiligo.
- Previous depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
- Use of protocol-defined treatments within the indicated washout period before baseline.
- Liver or renal damage.
- Allergic to any component of the investigational drug.
- Pregnant or lactating subjects. -
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicenter, randomized, double-blind, vehicle-controlled phase II study of MH004 Ointment with a 28-week open-label long-term safety extension period. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and primary efficacy of MH004 Ointment in adolescents and adults with vitiligo.
Read the detailed description
This phase II trial of MH004 Ointment comprises two periods: a vehicle control period and an open-label long-term safety extension period. Participants will be randomly aligned to the 1.0% MH004 Ointment or Vehicle arms and treated for up to 24 weeks, followed by a 28-week open-label LTS treatment period with 1.0% MH004 Ointment. The primary objective of this trial is to evaluate the efficacy of MH004 Ointment in adolescent and adult participants with vitiligo.
- Conditions
- Vitiligo
- Being tested
- MH004 Ointment, Vehicle Ointment
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MH004 OintmentDrug
MH004 1% ointment applied topically to the affected area as a thin film once or twice daily.
Vehicle OintmentDrug
Matching vehicle ointment applied topically to the affected area as a thin film once or twice daily.
| Study group | Role | What they receive |
|---|---|---|
| VC Period: MH004 1.0% Ointment QD | Experimental | Participants received MH004 1.0% Ointment once a day (QD) from Day 1 to Week 24 during the Vehicle Control (VC) Period. Receives: Drug: MH004 Ointment |
| VC Period: MH004 1.0% Ointment BID | Experimental | Participants received MH004 1.0% Ointment twice daily (BID) from Day 1 to Week 24 during the Vehicle Control (VC) Period. Receives: Drug: MH004 Ointment |
| VC Period: Vehicle Ointment QD | Placebo comparator | Participants received vehicle ointment QD from Day 1 to Week 24 during the VC Period. Receives: Drug: Vehicle Ointment |
| VC Period: Vehicle Ointment BID | Placebo comparator | Participants received vehicle ointment BID from Day 1 to Week 24 during the VC Period. Receives: Drug: Vehicle Ointment |
| LTS Period: 1.0% MH004 Ointment QD | Experimental | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied MH004 1.0% Ointment or Vehicle Ointment QD will apply MH004 1.0% Ointment QD from week 24 to week 52 during the LTS period. Receives: Drug: MH004 Ointment |
| LTS Period: 1.0% MH004 Ointment BID | Experimental | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied MH004 1.0% Ointment or Vehicle Ointment BID will apply MH004 1.0% Ointment BID from week 24 to week 52 during the LTS period. Receives: Drug: MH004 Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving Facial Vitiligo Area Scoring Index 50(F-VASI50) at Week 24.
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
Secondary outcomes (10)
Percentage of Participants Achieving a ≥ 75% Improvement from Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at 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).
Measured: Baseline; Week 24
Percentage of Participants Achieving a ≥ 50% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24
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
Percentage of Participants Achieving a ≥ 75% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Week 24
A T-VASI75 responder achieved at least 75% improvement from Baseline in T-VASI, calculated with contributions from 6 sites
Measured: Baseline; Week 24
Percentage Change from Baseline in Facial Body Surface Area (F-BSA) at Week 24
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 F-VASI 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 T-VASI 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
Proportion of participants achieving Facial Vitiligo Area Scoring Index 50(F-VASI50) at Week 52.
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
Percentage of Participants Achieving a ≥ 50% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 52
A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites.
Measured: Baseline; Week 52
Percentage Change From Baseline in T-BSA at Week 52
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
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been 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 TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application 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 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start26 Mar 2024
- Primary completion24 Sep 2025
- Study completion7 May 2026
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.
- More trials run by Minghui Pharmaceutical (Hangzhou) LtdThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
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
- NCT07181187
- Sponsor's protocol ID
- MH004-E-201
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 4 Jun 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of MH004 Ointment in Patients With Non-segmental Vitiligo
- ClinicalTrials.gov ID
- NCT07181187
- Acronym / sponsor ID
- MH004-E-201
- Conditions
- Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 18 Sep 2025 (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 multicenter, randomized, double-blind, vehicle-controlled phase II study of MH004 Ointment with a 28-week open-label long-term safety extension period. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and primary efficacy of MH004 Ointment in adolescents and adults with vitiligo.
Detailed description
This phase II trial of MH004 Ointment comprises two periods: a vehicle control period and an open-label long-term safety extension period. Participants will be randomly aligned to the 1.0% MH004 Ointment or Vehicle arms and treated for up to 24 weeks, followed by a 28-week open-label LTS treatment period with 1.0% MH004 Ointment. The primary objective of this trial is to evaluate the efficacy of MH004 Ointment in adolescent and adult participants with vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| VC Period: MH004 1.0% Ointment QD | Experimental | Drug: MH004 OintmentParticipants received MH004 1.0% Ointment once a day (QD) from Day 1 to Week 24 during the Vehicle Control (VC) Period. |
| VC Period: MH004 1.0% Ointment BID | Experimental | Drug: MH004 OintmentParticipants received MH004 1.0% Ointment twice daily (BID) from Day 1 to Week 24 during the Vehicle Control (VC) Period. |
| VC Period: Vehicle Ointment QD | Placebo comparator | Drug: Vehicle OintmentParticipants received vehicle ointment QD from Day 1 to Week 24 during the VC Period. |
| VC Period: Vehicle Ointment BID | Placebo comparator | Drug: Vehicle OintmentParticipants received vehicle ointment BID from Day 1 to Week 24 during the VC Period. |
| LTS Period: 1.0% MH004 Ointment QD | Experimental | Drug: MH004 OintmentParticipants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied MH004 1.0% Ointment or Vehicle Ointment QD will apply MH004 1.0% Ointment QD from week 24 to week 52 during the LTS period. |
| LTS Period: 1.0% MH004 Ointment BID | Experimental | Drug: MH004 OintmentParticipants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied MH004 1.0% Ointment or Vehicle Ointment BID will apply MH004 1.0% Ointment BID from week 24 to week 52 during the LTS period. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 12 to 65 years (inclusive) of either gender.
- Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face and total body vitiligo area not exceeding 20% BSA.
- Fully understand the trial content, voluntarily participate in the trial, and sign the ICF.
- Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.
- -
Key exclusion criteria (6 listed)
- Other dermatoses that may complicate the assessment of vitiligo.
- Previous depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
- Use of protocol-defined treatments within the indicated washout period before baseline.
- Liver or renal damage.
- Allergic to any component of the investigational drug.
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 OintmentMH004 1% ointment applied topically to the affected area as a thin film once or twice daily. | Drug | LTS Period: 1.0% MH004 Ointment BID, LTS Period: 1.0% MH004 Ointment QD, VC Period: MH004 1.0% Ointment BID, VC Period: MH004 1.0% Ointment QD |
| Vehicle OintmentMatching vehicle ointment applied topically to the affected area as a thin film once or twice daily. | Drug | VC Period: Vehicle Ointment BID, VC Period: Vehicle Ointment QD |
Primary outcome
Proportion of participants achieving Facial Vitiligo Area Scoring Index 50(F-VASI50) at Week 24.
Time frame: Baseline; Week 24
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).
10 secondary outcomes
Percentage of Participants Achieving a ≥ 75% Improvement from Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24
Time frame: Baseline; Week 24
Percentage of Participants Achieving a ≥ 50% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24
Time frame: Baseline; Week 24
Percentage of Participants Achieving a ≥ 75% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Week 24
Time frame: Baseline; Week 24
Percentage Change from Baseline in Facial Body Surface Area (F-BSA) at Week 24
Time frame: Baseline; Week 24
Percentage Change from Baseline in F-VASI at Week 24
Time frame: Baseline; Week 24
Percentage Change from Baseline in T-VASI at Week 52
Time frame: Baseline; Week 52
Proportion of participants achieving Facial Vitiligo Area Scoring Index 50(F-VASI50) at Week 52.
Time frame: Baseline; Week 52
Percentage of Participants Achieving a ≥ 50% Improvement from Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 52
Time frame: Baseline; Week 52
Percentage Change From Baseline in T-BSA at Week 52
Time frame: Baseline; Week 52
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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 52)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MH004 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 4 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving Facial Vitiligo Area Scoring Index 50(F-VASI50) at Week 24. (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 4 Jun 2026.