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RecruitingNCT07073677Updated Sep 9, 2026

A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients

A Phase 2 interventional study of IN-115314 Ointment 1% and IN-115314 Ointment 3% in Mild to Moderate Atopic Dermatitis, sponsored by HK inno.N Corporation. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by HK inno.N Corporation · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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
  1. 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.

  2. 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.
02

Conditions studied

  • Mild to Moderate Atopic Dermatitis

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03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 162 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

HK inno.N Corporation is the lead sponsor of 102 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult volunteers aged 19 or older when the is obtained.
  2. Confirmed diagnosis of AD according the criteria of Hanifin and Rajka (1980).
  3. AD lesions that can be applied by product
  4. 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

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have the following prior/current history in addition to evidence or history of skin disorders other than AD ( e.g., psoriasis, contact dermatitis, erythroderma)
  2. 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)
  3. 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.)
  4. 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)
  5. Subjects who have taken systemic anti-inflammatory for chronic or acute inflammatory disease within 2 weeks prior to the expected initial application date
  6. Subjects who have a history of clinical significant reactions to product , other drugs (aspirin, penicillin antibiotics, macrolide antibiotics, etc.) and moisturizers provided by sponsor (anaphylaxis or angioedema, etc.)
  7. 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
    • Oral Janus kinase (JAK) inhibitor medication
    • a
    • systemic retinoid
    • phototherapy treatment
    • Systemic

    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
  8. Subjects who have clinically significant findings on 12-lead at screening
  9. The following clinically significant findings on laboratory examination at screening

    • \< 10 g/dL
    • or ANC level \< 0.5 x lower limit of normal
    • , ALT, ALP, γ-GTP is ≥ 2 or total level is ≥ 1.5 x ;
    • Serum creatinine level is ≥ 2 x upper limit of normal;
    • Positive anti-, HBs Ag, Ag/Ab, or IGRA test.
  10. Subjects who have uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg)
  11. Subjects who have history of drug or alcohol abuse in 56 weeks at screening
  12. 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 to PSV.
  13. Subjects who have participated in other clinical trials within 4 weeks prior to the expected initial application date
  14. Subjects who have scheduled surgery requiring hospitalization or requires surgical treatment over the clinical trial
  15. Subjects or spouses (or partners) who have a plan for pregnancy or although unplanned pregnancy, are unable to use a highly effective method of over a period from the informed consent to 90 days after the last dose of investigational product.
  16. Pregnant or lactating woman
  17. Naive in atopic dermatitis treatment
  18. Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
162 participants (estimated)

Study arms

  • Experimental
    J1

    IN-115314 Ointment 1%

    Drug: IN-115314 Ointment 1%

  • Experimental
    J3

    IN-115314 Ointment 3%

    Drug: IN-115314 Ointment 3%

  • Placebo comparator
    PJ

    IN-115314 Ointment Placebo

    Drug: IN-115314 Ointment placebo

Interventions

  • DrugIN-115314 Ointment 1%

    Twice daily(BID), for 56 day

  • DrugIN-115314 Ointment 3%

    Twice daily(BID), for 56 day

  • DrugIN-115314 Ointment placebo

    Twice daily(BID), IN-115314 Ointment Placebo for 28 days+ IN-115314 Ointment 3% for 28 days

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 1 week, 2 weeks

  2. 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.

    Time frame: 1 week, 2 weeks, 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07073677
Responsible party
Sponsor
First posted
Jul 18, 2025
Start date
Aug 12, 2025
Primary completion
Jul 13, 2026
Completion
Sep 30, 2026 (estimated)
Last update
Sep 9, 2026

Study contacts

Haerim Jang
Contact
haerim.jang@inno-n.com
+82- 31-5176-4659
Yugyeong Park
Contact
yugyeong.park@inno-n.com
+82- 31-5176-4661
Son Sang Wook
principal investigator · Korea University Ansan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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