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

NCT07158151 | Completed Phase 2

• 1 other identifier: RSS0393Oint-202
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis of Adults

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with vIGA-AD success

  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

  Baseline, week 4

Secondary Outcomes (4)

• Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)

  Up to 8 weeks

• Percentage of subjects with vIGA-AD of "clear" or "almost clear"

  Up to 8 weeks

• The change of WI-NRS

  Up to 8 weeks

• Safety: treatment emergence adverse events

  Up to 8 weeks

Study Arms (4)

Treatment group 1: RSS0393 ointment 0.05%

EXPERIMENTAL

Drug: RSS0393 ointment

Treatment group 2: RSS0393 ointment 0.01%

EXPERIMENTAL

Drug: RSS0393 ointment

Treatment group 3: RSS0393 ointment 0.03%

EXPERIMENTAL

Drug: RSS0393 ointment

Treatment group 4: RSS0393 ointment placebo

SHAM COMPARATOR

Drug: RSS0393 ointment

Interventions

RSS0393 ointment DRUG

RSS0393 ointment 0.05%

Treatment group 1: RSS0393 ointment 0.05%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old and ≤75 years old at screening.
• History of atopic dermatitis ≥ 6 months.
• BSA is between 3% and 20% (inclusive) and EASI score is ≥ 5 and vIGA-AD is 2 or 3.
• The subjects signed informed consent before any study-related procedures began.

You may not qualify if:

• Diagnosis of other dermatologic diseases at screening.
• Subjects have other skin diseases or conditions that may affect the evaluation of the relevant endpoints of this study.
• Subjects with any other persistent active autoimmune disease.
• 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.

Sponsors & Collaborators

• Reistone Biopharma Company Limited: lead

Study Sites (1)

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: September 25, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-08

Locations

CN (1)