A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amorepacific Corporation

Criteria

Inclusion Criteria:

• Male and female patients aged 24 months - 12 years

• Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria, whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).

• Who has applied stable amount of emollients daily before baseline visit

• 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, psychial disorder that can affect study results.

• Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.

• Who has used topical steroids, immunosuppressants 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.