New ointment aims to restore skin color in vitiligo

NCT ID NCT07682506

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether an ointment called MH004 can help restore skin color in people with non-segmental vitiligo. The study includes adolescents and adults aged 12 to 75 with facial vitiligo. Participants apply the ointment twice daily for 24 weeks, and researchers measure improvement in skin repigmentation compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MH004 ointment
What this could lead to
If successful, this could offer a new topical treatment to restore skin color in people with vitiligo.
What could go wrong
This is a Phase 3 trial, so results are not yet confirmed. The ointment may not work for everyone, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 405 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects aged 12 to 75 years inclusive at the time of signing the Informed Consent Form (ICF), with no restriction on gender. 2. Clinically diagnosed with non-segmental vitiligo. 3. 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. 4. 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. 5. 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. 6. 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. Exclusion Criteria: 1. All terminal hairs (i.e., beard, eyebrows, eyelashes) within facial vitiligo areas are depigmented white. 2. Other subtypes of vitiligo or hypopigmentary disorders 1. Segmental vitiligo, unclassified vitiligo, or mixed vitiligo; 2. 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.). 3. Specific prior treatment history: 1. Prior use of any JAK inhibitor (systemic or topical) for vitiligo treatment at any time; 2. Prior depigmentation therapy for vitiligo (e.g., monobenzone), excluding hydroquinone; 3. Prior melanocyte-keratinocyte transplantation or other surgical procedures for vitiligo on the face. 4. Treatments administered within the required washout period 1. Use of biologic agents within 12 weeks or 5 half-lives (whichever is longer) prior to the first study drug administration; 2. Receipt of laser therapy or any form of phototherapy (including tanning beds) within 8 weeks prior to the first study drug administration; 3. 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; 4. Oral traditional Chinese medicines for vitiligo within 2 weeks prior to the first study drug administration; 5. 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); 5. 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. 6. Concomitant diseases or medical history that may interfere with the study 7. Specific risks of cardiovascular and thromboembolic events 8. Active or latent infections 9. Positive virology screening results at screening 10. History of malignancy 11. Clinically significant abnormal laboratory values 12. 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). 13. Planned administration of live or live-attenuated vaccines during the study period. 14. Female subjects who are pregnant or breastfeeding. 15. 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. 16. Hypersensitivity and intolerance Known hypersensitivity to the investigational product or any excipient components. 17. Other exclusion factors 1. History of alcohol abuse or substance misuse; 2. Subjects shall avoid intentional excessive sun exposure during the study (e.g., prolonged sunbathing, sun exposure for tanning purposes); 3. Body mass index (BMI) \< 16 kg/m² or \> 40 kg/m², where BMI = weight (kg) / height² (m²); 4. Any other conditions deemed inappropriate for study participation by the Investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

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