New eczema ointment shows promise in Late-Stage trial
NCT ID NCT07185282
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This Phase 3 study tested MH004 ointment in 375 adolescents and adults with mild to moderate atopic dermatitis (eczema). Participants applied the ointment or a placebo twice daily for 4 weeks, followed by a 44-week safety extension. The main goals were to see if the ointment could clear or nearly clear the skin and reduce eczema severity by at least 75%.
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 provide a new topical treatment option for people with mild to moderate atopic dermatitis, helping to clear skin and reduce eczema severity.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet published. The ointment may not work better than a placebo, and long-term safety data are still being analyzed.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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375 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Aug 2025
- Lead sponsor
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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
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Adolescents aged ≥ 12 to 17 years, inclusive, and men and women aged ≥18 years. 2. Clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 1 year prior to Day 1. 3. Participants meet all the following atopic dermatitis criteria: VC period: IGA 2 to 3, affected BSA 3% to 20% (excluding scalp) at the baseline visit. LTS period: IGA 0 to 4, affected BSA 0% to 20% (excluding scalp) at Week 8. 4. Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit. 5. Participants who have at least one AD lesion not located on the hands, feet, or genitalia. 6. Willingness to avoid pregnancy or fathering of children. - Exclusion Criteria: 1. Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline. 2. Concurrent conditions and history of other diseases: * Immunocompromised. * Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline. * Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline. * Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety. * Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds. * Other types of eczema. 3. 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. 4. 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. 5. Previously received Janus kinase (JAK) inhibitors, systemic or topical. 6. Ultraviolet light therapy or prolonged exposure to UV radiation within 2 weeks before dosing. 7. Liver function tests: AST or ALT ≥ 2 × ULN; alkaline phosphatase and/or bilirubin \> 1.5 × ULN. 8. Pregnant or lactating participants, or those considering pregnancy. 9. Alcohol or drug abuse. -
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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.
Contacts and locations
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.