NCT07073677

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of IN-115314 Ointment in mild to moderate atopic dermatitis adult patients

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.

Conditions

• Mild to Moderate Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	IN-115314 Ointment 1%	Twice daily(BID), for 56 day
DRUG	IN-115314 Ointment 3%	Twice daily(BID), for 56 day
DRUG	IN-115314 Ointment placebo	Twice daily(BID), IN-115314 Ointment Placebo for 28 days+ IN-115314 Ointment 3% for 28 days

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-07-18
• Last updated: 2025-07-18