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

NCT ID: NCT02757729

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31

Brief Summary

This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

Detailed Description

PAC-14028 Cream (0.1%, 0.3%, 1.0%) or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

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 8 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 8 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 8 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 8 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 19 - 70 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 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 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: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amorepacific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beomjoon Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Locations

Chung-ang University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AP-TRPV1-PII_04

Identifier Type: -

Identifier Source: org_study_id