A Phase II Trial of the Safety and Efficacy of RSS0309 Ointment in Adults With Atopic Dermatitis
NCT ID: NCT07158151
Last Updated: 2025-11-19
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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RECRUITING
PHASE2
168 participants
INTERVENTIONAL
2025-09-25
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group 1: RSS0393 ointment 0.05%
RSS0393 ointment
RSS0393 ointment 0.05%
Treatment group 2: RSS0393 ointment 0.01%
RSS0393 ointment
RSS0393 ointment 0.01%
Treatment group 3: RSS0393 ointment 0.03%
RSS0393 ointment
RSS0393 ointment 0.03%
Treatment group 4: RSS0393 ointment placebo
RSS0393 ointment
RSS0393 ointment placebo
Interventions
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RSS0393 ointment
RSS0393 ointment 0.05%
RSS0393 ointment
RSS0393 ointment 0.01%
RSS0393 ointment
RSS0393 ointment 0.03%
RSS0393 ointment
RSS0393 ointment placebo
Eligibility Criteria
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Inclusion Criteria
2. History of atopic dermatitis ≥ 6 months.
3. BSA is between 3% and 20% (inclusive) and EASI score is ≥ 5 and vIGA-AD is 2 or 3.
4. The subjects signed informed consent before any study-related procedures began.
Exclusion Criteria
2. Subjects have other skin diseases or conditions that may affect the evaluation of the relevant endpoints of this study.
3. Subjects with any other persistent active autoimmune disease.
4. Subjects who have received topical medication for psoriasis within 14 days before baseline, or systemic medication or phototherapy for psoriasis within 28 days before baseline, or biological agents for psoriasis within a specified time before baseline.
18 Years
75 Years
ALL
No
Sponsors
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Reistone Biopharma Company Limited
INDUSTRY
Responsible Party
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Locations
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Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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RSS0393Oint-202
Identifier Type: -
Identifier Source: org_study_id
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