A Phase 3 Study of MH004 Ointment in Patients With Mild to Moderate Atopic Dermatitis (NCT07185282) | Clinical Trial Compass
CompletedPhase 3
A Phase 3 Study of MH004 Ointment in Patients With Mild to Moderate Atopic Dermatitis
China375 participantsStarted 2023-06-10
Plain-language summary
This is a multicenter, randomized, double-blind, vehicle-controlled phase III study of MH004 Ointment with a 44-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 mild to moderate atopic dermatitis.
Who can participate
Age range
12 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
. Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥18 years.
. Clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 1 year prior to Day 1.
. Participants meet all the following atopic dermatitis criteria:
. Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
. Participants who have at least one AD lesion not located on the hands, feet, or genitalia.
. Willingness to avoid pregnancy or fathering of children. -
Exclusion criteria
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
1
Proportion of participants achieving Investigator's Global Assessment treatment success (IGA-TS) at Week 4.
Timeframe: Baseline to week 4.
2
Proportion of participants achieving EASI-75 at Week 4.
. 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.
. Ultraviolet light therapy or prolonged exposure to UV radiation within 2 weeks before dosing.
. Liver function tests: AST or ALT ≥ 2 × ULN; alkaline phosphatase and/or bilirubin \> 1.5 × ULN.
. Pregnant or lactating participants, or those considering pregnancy.