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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorHK inno.N Corporation

About this trial

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

Eligibility criteria

Qualifiers

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 <

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • IN-115314 Ointment 1%
  • IN-115314 Ointment 3%
  • IN-115314 Ointment placebo

Treatment groups

162 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators