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Completed

NCT Number: NCT07158151

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

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

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Key information

Conditions

Atopic Dermatitis of Adults

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

RSS0393 Ointment

Drug

RSS0393 ointment 0.05%

Primary outcomes

  1. Percentage of subjects with vIGA-AD success

    Time frame: 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 outcomes

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

    Time frame: 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).

  2. Percentage of subjects with vIGA-AD of "clear" or "almost clear"

    Time frame: 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).

  3. The change of WI-NRS

    Time frame: 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.

  4. Safety: treatment emergence adverse events

    Time frame: Up to 8 weeks

Sponsors and collaborators

Lead sponsor

Reistone Biopharma Company Limited

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of RSS0393 Ointment in Adults With Mild to Moderate Atopic Dermatitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.