Mild to Moderate Atopic DermatitisPhase 2NCT07073677
A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients
A Phase 2 study testing IN-115314 Ointment 1% and IN-115314 Ointment 3% in people with Mild to Moderate Atopic Dermatitis, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate the efficacy and safety of IN-115314 Ointment in mild to moderate atopic dermatitis adult patients Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mild to Moderate Atopic Dermatitis
- What is being tested?
- IN-115314 Ointment 1% and IN-115314 Ointment 3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2025to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult volunteers aged 19 or older when the informed consent is obtained.
- Confirmed diagnosis of AD according the criteria of Hanifin and Rajka (1980).
- AD lesions that can be applied by investigational product
- AD diagnosed by EASI score of mild (EASI < 16) or moderate (16 ≤ EASI <
- 23) at screening. 5) Subjects who Investigator Global Assessment (IGA) of 2 to 3 at screening 6) Subjects who have a history of AD at least 12 months prior to screening and who have not improved or worsened the disease for at least one month prior to screening 7) Subjects who voluntarily decide to participate and agree to comply with the requirements
Who cannot join
- Subjects who have the following prior/current history in addition to evidence or history of clinically significant skin disorders other than AD ( e.g., psoriasis, contact dermatitis, erythroderma)
- Subjects who have the following prior/current history in addition to evidence or history of clinically significant skin disorders (e.g., hepatic, renal, Cardiovascular, respiratory, endocrine, neurological, hematological, immunological or immunodeficiency disease)
- Subjects who have a history of malignant tumors within 5 years at screening (but, those who have passed five years without recurrence after active tumor treatment (surgery, chemotherapy, radiation therapy, etc.) can participate.)
- Subjects who have clinically significant systemic or local skin infections or clinical signs of such infections within one week prior to the expeced initial application date (e.g., herpes simplex, shingles, chickenpox)
- Subjects who have taken systemic anti-inflammatory for chronic or acute inflammatory disease within 2 weeks prior to the expected initial application date
- Subjects who have a history of clinical significant hypersensitivity reactions to Investigational product , other drugs (aspirin, penicillin antibiotics, macrolide antibiotics, etc.) and moisturizers provided by sponsor (anaphylaxis or angioedema, etc.)
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- Subjects who have administered the following drugs within the specified period before the expected initial application date; subjects who are expected to be administered within the clinical trial period; subjects who are unable to stop administration Biological agents that may affect signs and symptoms of AD within 12 weeks (e.g., dupilumab)
- The following medications and treatments that may affect the signs and symptoms of atopic dermatitis within 4 weeks:
- Systemic immunosuppressants/immunosuppressants
- Oral Janus kinase (JAK) inhibitor medication
- a live vaccine
- systemic retinoid
- phototherapy treatment
- Systemic corticosteroids
- The following medications and treatments that may affect the signs and symptoms of atopic dermatitis within two weeks:
- a systemic anti-inflammatory drug
- systemic anti-microbial agents
- bleach treatment
- The following medications that may affect the signs and symptoms of atopic dermatitis within one week:
- topical corticosteroids
- topical calcineurin inhibitor
- topical antihistamines
- a topical anti-microbial agent
- a topical PDE-4 inhibitor
- topical retinoid
- Oral antihistamines
- Subjects who have clinically significant findings on 12-lead ECG at screening
- The following clinically significant findings on laboratory examination at screening
- Hb < 10 g/dL
- Platelet or ANC level < 0.5 x lower limit of normal
- AST, ALT, ALP, γ-GTP is ≥ 2 or total bilirubin level is ≥ 1.5 x upper limit of normal;
- Serum creatinine level is ≥ 2 x upper limit of normal;
- Positive anti-HCV, HBs Ag, HIV Ag/Ab, or IGRA test.
- Subjects who have uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg)
- Subjects who have history of drug or alcohol abuse in 56 weeks at screening
- Subjects who have donated whole blood or apheresis within 4 weeks prior to the expected initial application date or received blood transfusion within 4 weeks prior to the expected initial application date, or subjects who cannot continuously abstain from blood donation over a period from the informed consent to PSV.
- Subjects who have participated in other clinical trials within 4 weeks prior to the expected initial application date
- Subjects who have scheduled surgery requiring hospitalization or requires surgical treatment over the clinical trial
- Subjects or spouses (or partners) who have a plan for pregnancy or although unplanned pregnancy, are unable to use a highly effective method of contraception over a period from the informed consent to 90 days after the last dose of investigational product.
- Pregnant or lactating woman
- Naive in atopic dermatitis treatment
- Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea university Ansan hospital
Ansan, ALL, 15355
Korea university Ansan hospital, 01082795183, skin4u@korea.ac.kr
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients
This study aims to evaluate the efficacy and safety of IN-115314 Ointment in mild to moderate atopic dermatitis adult patients
Read the detailed description
- Primary Objective
- To evaluate the efficacy of IN-115314 ointment (1%, 3%) compared to placebo after multiple dosing, twice a day, in mild to moderate atopic dermatitis adult patients.
- Secondary Objective
- To evaluate the safety of IN-115314 ointment (1%, 3%) after multiple dosing, twice a day, in mild to moderate atopic dermatitis adult patients.
- To evaluate the pharmacokinetic(PK) profile of IN-115314 ointment (1%, 3%) after multiple dosing ,twice a day, in mild to moderate atopic dermatitis adult patients.
- Conditions
- Mild to Moderate Atopic Dermatitis
- Being tested
- IN-115314 Ointment 1%, IN-115314 Ointment 3%, IN-115314 Ointment placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-115314 Ointment 1%Drug
Twice daily(BID), for 56 day
IN-115314 Ointment 3%Drug
Twice daily(BID), for 56 day
IN-115314 Ointment placeboDrug
Twice daily(BID), IN-115314 Ointment Placebo for 28 days+ IN-115314 Ointment 3% for 28 days
| Study group | Role | What they receive |
|---|---|---|
| J1 | Experimental | IN-115314 Ointment 1% Receives: Drug: IN-115314 Ointment 1% |
| J3 | Experimental | IN-115314 Ointment 3% Receives: Drug: IN-115314 Ointment 3% |
| PJ | Placebo comparator | IN-115314 Ointment Placebo Receives: Drug: IN-115314 Ointment placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rate in EASI (Eczema Area and Severity Index) score from the baseline after treatment
Eczema Area and Severity Index (EASI) score ranges from 0 to 72, Higher scores mean worse outcome.
Measured: 4 weeks
Secondary outcomes (2)
Change rate in EASI (Eczema Area and Severity Index) score from the baseline after treatment
Eczema Area and Severity Index (EASI) score ranges from 0 to 72, Higher scores mean worse outcome.
Measured: 1 week, 2 weeks
Changes in EASI (Eczema Area and Severity Index) score from the baseline after treatment
Eczema Area and Severity Index (EASI) score ranges from 0 to 72, Higher scores mean worse outcome.
Measured: 1 week, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start12 Aug 2025
- Primary completion13 Jul 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Son Sang Wook, Principal investigator, Korea University Ansan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073677
- Sponsor's protocol ID
- IN_JSI_201
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients
- ClinicalTrials.gov ID
- NCT07073677
- Acronym / sponsor ID
- IN_JSI_201
- Conditions
- Mild to Moderate Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Jul 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 aims to evaluate the efficacy and safety of IN-115314 Ointment in mild to moderate atopic dermatitis adult patients
Detailed description
- Primary Objective
- To evaluate the efficacy of IN-115314 ointment (1%, 3%) compared to placebo after multiple dosing, twice a day, in mild to moderate atopic dermatitis adult patients.
- Secondary Objective
- To evaluate the safety of IN-115314 ointment (1%, 3%) after multiple dosing, twice a day, in mild to moderate atopic dermatitis adult patients.
- To evaluate the pharmacokinetic(PK) profile of IN-115314 ointment (1%, 3%) after multiple dosing ,twice a day, in mild to moderate atopic dermatitis adult patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| J1 | Experimental | Drug: IN-115314 Ointment 1%IN-115314 Ointment 1% |
| J3 | Experimental | Drug: IN-115314 Ointment 3%IN-115314 Ointment 3% |
| PJ | Placebo comparator | Drug: IN-115314 Ointment placeboIN-115314 Ointment Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult volunteers aged 19 or older when the informed consent is obtained.
- Confirmed diagnosis of AD according the criteria of Hanifin and Rajka (1980).
- AD lesions that can be applied by investigational product
- AD diagnosed by EASI score of mild (EASI < 16) or moderate (16 ≤ EASI <
- 23) at screening. 5) Subjects who Investigator Global Assessment (IGA) of 2 to 3 at screening 6) Subjects who have a history of AD at least 12 months prior to screening and who have not improved or worsened the disease for at least one month prior to screening 7) Subjects who voluntarily decide to participate and agree to comply with the requirements
Key exclusion criteria (42 listed)
- Subjects who have the following prior/current history in addition to evidence or history of clinically significant skin disorders other than AD ( e.g., psoriasis, contact dermatitis, erythroderma)
- Subjects who have the following prior/current history in addition to evidence or history of clinically significant skin disorders (e.g., hepatic, renal, Cardiovascular, respiratory, endocrine, neurological, hematological, immunological or immunodeficiency disease)
- Subjects who have a history of malignant tumors within 5 years at screening (but, those who have passed five years without recurrence after active tumor treatment (surgery, chemotherapy, radiation therapy, etc.) can participate.)
- Subjects who have clinically significant systemic or local skin infections or clinical signs of such infections within one week prior to the expeced initial application date (e.g., herpes simplex, shingles, chickenpox)
- Subjects who have taken systemic anti-inflammatory for chronic or acute inflammatory disease within 2 weeks prior to the expected initial application date
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 |
|---|---|---|
| IN-115314 Ointment 1%Twice daily(BID), for 56 day | Drug | J1 |
| IN-115314 Ointment 3%Twice daily(BID), for 56 day | Drug | J3 |
| IN-115314 Ointment placeboTwice daily(BID), IN-115314 Ointment Placebo for 28 days+ IN-115314 Ointment 3% for 28 days | Drug | PJ |
Primary outcome
Change rate in EASI (Eczema Area and Severity Index) score from the baseline after treatment
Time frame: 4 weeks
Eczema Area and Severity Index (EASI) score ranges from 0 to 72, Higher scores mean worse outcome.
2 secondary outcomes
Change rate in EASI (Eczema Area and Severity Index) score from the baseline after treatment
Time frame: 1 week, 2 weeks
Changes in EASI (Eczema Area and Severity Index) score from the baseline after treatment
Time frame: 1 week, 2 weeks, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Son Sang Wook principal investigator
Korea University Ansan Hospital
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 IN-115314 Ointment 1% and IN-115314 Ointment 3% in people with Mild to Moderate Atopic Dermatitis, run by HK inno.N Corporation at 1 site in South Korea.
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 5 inclusion and 42 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: looking for participants now, as of the sponsor's last update on 9 Sep 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haerim Jang (+82- 31-5176-4659, haerim.jang@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change rate in EASI (Eczema Area and Severity Index) score from the baseline after treatment (time frame: 4 weeks). 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 9 Sep 2026.