A Phase II Trial of the Safety and Efficacy of RSS0309 Ointment in Adults With Atopic Dermatitis

Not Applicable

Not yet recruiting

• Conditions: Atopic Dermatitis of Adults
• Interventions: Drug: RSS0393 ointment

• Registration Number: NCT07158151
• Lead Sponsor: Reistone Biopharma Company Limited

Brief Summary

This study is ongoing to explore the efficacy and safety of different strengths of RSS0393 ointment in adults with atopic dermatitis

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study Start: 2025-09-01
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2026-03
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

1. Age ≥18 years old and ≤75 years old at screening.
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

1. Diagnosis of other dermatologic diseases at screening.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 1: RSS0393 ointment 0.05%	RSS0393 ointment	-
Treatment group 2: RSS0393 ointment 0.01%	RSS0393 ointment	-
Treatment group 3: RSS0393 ointment 0.03%	RSS0393 ointment	-
Treatment group 4: RSS0393 ointment placebo	RSS0393 ointment	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with vIGA-AD success	Baseline, week 4	The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear). IGA sucess is defined as a vIGA-AD score of 'clear' or 'almost clear' plus at least 2-grade improvement from baseline

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)	Up to 8 weeks	EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease).
Percentage of subjects with vIGA-AD of "clear" or "almost clear"	Up to 8 weeks	The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
Safety: treatment emergence adverse events	Up to 8 weeks
The change of WI-NRS	Up to 8 weeks	The Worst Itch Numerical Rating Scale (WI-NRS) will be determined by the subject's recording of daily assessment of worst itch over the past 24 hours.

Trial Locations

Locations (1)

Dermatology Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China