CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis

Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase III Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients

This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

PAC-14028 cream 1.0% or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

Inclusion Criteria:

• Male and female patients aged 12 - 70 years.
• Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.
• Whose affected TBSA is over 5% and below 30%, and IGA score is 2 (mild) to 3 (moderate).
• Who voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

• Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
• Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
• Who has used systemic steroids, antibiotics, immunosuppressants, or received phototherapy within 28 days before study drug administration.
• Who has used topical steroids, topical calcineurin inhibitors or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
• Who has used or is expected to inevitably use prohibited concomitant medications during the study.
• Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
• Who has dosed other study medications within 30 days before screening.
• Who is determined ineligible for study participation by investigators for any other reasons.