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

NCT ID: NCT02748993

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-10-31

Brief Summary

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

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PAC-14028 Cream 0.1%

PAC-14028 Cream 0.1%, Twice daily for 4 weeks

Group Type: EXPERIMENTAL

PAC-14028 Cream 0.1%

Intervention Type: DRUG

Topical application

PAC-14028 Cream 0.3%

PAC-14028 Cream 0.3%, Twice daily for 4 weeks

Group Type: EXPERIMENTAL

PAC-14028 Cream 0.3%

Intervention Type: DRUG

Topical application

PAC-14028 Cream 1.0%

PAC-14028 Cream 1.0%, Twice daily for 4 weeks

Group Type: EXPERIMENTAL

PAC-14028 Cream 1.0%

Intervention Type: DRUG

Topical application

PAC-14028 Cream Vehicle

PAC-14028 Cream Vehicle, twice daily for 4 weeks

Group Type: PLACEBO_COMPARATOR

PAC-14028 Cream Vehicle

Intervention Type: DRUG

Topical application

Interventions

PAC-14028 Cream 0.1%

Topical application

Intervention Type: DRUG

PAC-14028 Cream 0.3%

Topical application

Intervention Type: DRUG

PAC-14028 Cream 1.0%

Topical application

Intervention Type: DRUG

PAC-14028 Cream Vehicle

Topical application

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amorepacific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyuhan Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Chung-ang University Hospital

Seoul, , South Korea

Konkuk University Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AP-TRPV1_PII-05

Identifier Type: -

Identifier Source: org_study_id