A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Derm… (NCT07073677) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients
162 participantsStarted 2025-07
Plain-language summary
This study aims to evaluate the efficacy and safety of IN-115314 Ointment in mild to moderate atopic dermatitis adult patients
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 \<
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change rate in EASI score from the baseline after treatment
. 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.)
. 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)
. Subjects who have clinically significant findings on 12-lead ECG at screening