Atopic Dermatitis of AdultsPhase 2NCT07158151
A Phase II Trial of the Safety and Efficacy of RSS0309 Ointment in Adults With Atopic Dermatitis
A Phase 2 study testing RSS0393 ointment in people with Atopic Dermatitis of Adults, run by Reistone Biopharma Company Limited at 1 site in China.
Trial summary
This study is ongoing to explore the efficacy and safety of different strengths of RSS0393 ointment in adults with atopic dermatitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis of Adults
- What is being tested?
- RSS0393 ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 10 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
About this study
Official 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
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
- Being tested
- RSS0393 ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSS0393 ointmentDrug
RSS0393 ointment 0.05%
RSS0393 ointmentDrug
RSS0393 ointment 0.01%
RSS0393 ointmentDrug
RSS0393 ointment 0.03%
RSS0393 ointmentDrug
RSS0393 ointment placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1: RSS0393 ointment 0.05% | Experimental | Not described Receives: Drug: RSS0393 ointment |
| Treatment group 2: RSS0393 ointment 0.01% | Experimental | Not described Receives: Drug: RSS0393 ointment |
| Treatment group 3: RSS0393 ointment 0.03% | Experimental | Not described Receives: Drug: RSS0393 ointment |
| Treatment group 4: RSS0393 ointment placebo | Sham comparator | Not described Receives: Drug: RSS0393 ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, week 4
Secondary outcomes (4)
Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)
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).
Measured: Up to 8 weeks
Percentage of subjects with vIGA-AD of "clear" or "almost clear"
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).
Measured: Up to 8 weeks
The change of WI-NRS
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.
Measured: Up to 8 weeks
Safety: treatment emergence adverse events
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start25 Sep 2025
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis of AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reistone Biopharma Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158151
- Sponsor's protocol ID
- RSS0393Oint-202
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07158151
- Acronym / sponsor ID
- RSS0393Oint-202
- Conditions
- Atopic Dermatitis of Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Reistone Biopharma Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is ongoing to explore the efficacy and safety of different strengths of RSS0393 ointment in adults with atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSS0393 ointmentRSS0393 ointment 0.05% | Drug | Treatment group 1: RSS0393 ointment 0.05% |
| RSS0393 ointmentRSS0393 ointment 0.01% | Drug | Treatment group 2: RSS0393 ointment 0.01% |
| RSS0393 ointmentRSS0393 ointment 0.03% | Drug | Treatment group 3: RSS0393 ointment 0.03% |
| RSS0393 ointmentRSS0393 ointment placebo | Drug | Treatment group 4: RSS0393 ointment placebo |
Primary outcome
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
4 secondary outcomes
Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)
Time frame: Up to 8 weeks
Percentage of subjects with vIGA-AD of "clear" or "almost clear"
Time frame: Up to 8 weeks
The change of WI-NRS
Time frame: Up to 8 weeks
Safety: treatment emergence adverse events
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RSS0393 ointment in people with Atopic Dermatitis of Adults, run by Reistone Biopharma Company Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with vIGA-AD success (time frame: Baseline, week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.