CompletedPhase 1/2

MH004 Ointment in Healthy Adult Volunteers and Participants With Mild to Moderate Atopic Dermatitis

China160 participantsStarted 2022-01-06

Plain-language summary

This is a Phase I/II Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis.

Who can participate

Age range

12 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Phase I: Adults, age 18 - 70 years old, inclusive. Phase II: Adolescents aged ≥ 12 to 17 years, inclusive. Adults, age 18 - 70 years old, inclusive, at time of screening.
. Phase II: clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 6 months prior to Day 1.
. Phase II: IGA 2 to 3, affected BSA 3% to 20% (excluding scalp) at the baseline visit.
. Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.

Exclusion criteria

. Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
. Concurrent conditions and history of other diseases:
. Clinically significant cardiac disease; new cerebral infarction within 6 months from dosing; malignancies within 5 years from dosing; low hemoglobin; severe renal disease on dialysis; liver disease.
. Systemic corticosteroids treated within 4 weeks before dosing; immunizations or sedating antihistamines treated within 4 weeks before dosing; other topical treatments for AD within 1 week before dosing.
. Previously received Janus kinase (JAK) inhibitors, systemic or topical.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase I: Incidence and severity of Treatment-Emergent Adverse Events (Safety and Tolerability)

Timeframe: 1 year

Phase II: Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With MH004 Ointment

Timeframe: Baseline and week 4.

Trial details

NCT IDNCT07182864

SponsorMinghui Pharmaceutical (Hangzhou) Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-08

View on ClinicalTrials.gov More Atopic Dermatitis (AD) trials