Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis
NCT ID: NCT06309355
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2024-06-19
2025-11-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active dose
The intervention is YR001 ointment on a range of body surface area for multiple topical administration
YR001 ointment
The intervention is YR001 ointment on a range of body surface area for multiple topical administration
Placebo dose
The intervention is Placebo on a range of body surface area for multiple topical administration
Placebo
The intervention is Placebo on a range of body surface area for multiple topical administration
Interventions
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YR001 ointment
The intervention is YR001 ointment on a range of body surface area for multiple topical administration
Placebo
The intervention is Placebo on a range of body surface area for multiple topical administration
Eligibility Criteria
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Inclusion Criteria
2. Male or female subject is aged 18 or older.
3. Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
4. An Investigator Static Global Assessment (ISGA) score of 2 (mild) to 3 (moderate) at screening and Baseline.
Exclusion Criteria
2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
3. Patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
4. Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response.
5. Participation in another interventional clinical trial (e.g. investigational drug, biological agent, or device) within 30 days or 5 half-lives of investigational agent (whichever is longer) before entering, or during the trial, or previous participation in this clinical trial.
18 Years
ALL
No
Sponsors
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Hangzhou Yirui Pharmaceutical Technology Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Encore Medical Research -Boynton Beach
Boynton Beach, Florida, United States
Encore Medical Research-Hollywood
Hollywood, Florida, United States
Encore Medical Research-Weston
Weston, Florida, United States
DelRicht Research
Baton Rouge, Louisiana, United States
Countries
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Other Identifiers
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YR001-A03
Identifier Type: -
Identifier Source: org_study_id