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

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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: PAC-14028 cream 0.1%; Drug: PAC-14028 cream 0.3%; Drug: PAC-14028 cream 1.0%; Drug: PAC-14028 cream vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAC-14028 cream 0.1%; PAC-14028 cream 0.1%, Twice daily for 8 weeks	Drug: PAC-14028 cream 0.1%; Topical application
Experimental: PAC-14028 cream 0.3%; PAC-14028 cream 0.3%, Twice daily for 8 weeks	Drug: PAC-14028 cream 0.3%; Topical application
Experimental: PAC-14028 cream 1.0%; PAC-14028 cream 1.0%, Twice daily for 8 weeks	Drug: PAC-14028 cream 1.0%; Topical application
Placebo Comparator: PAC-14028 cream vehicle; PAC-14028 cream vehicle, Twice daily for 8 weeks	Drug: PAC-14028 cream vehicle; Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of Investigator's Global Assessment (IGA)	percent of patients with IGA score of 0 (clear) or 1 (almost clear)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of Investigator's Global Assessment (IGA)	percent of patients with IGA score of 0 (clear) or 1 (almost clear)	1, 3, 6 week(s)
Change in SCORAD (Severity Score of Atopic Dermatitis)		1, 3, 6, 8 week(s)
% Change in Eczema Area and Severity Index (EASI)		1, 3, 6, 8 week(s)
Success rate of Pruritus Severity score		1, 3, 6, 8 week(s)

Collaborators and Investigators

• Sponsor: Amorepacific Corporation
• Investigators: Principal Investigator: Beomjoon Kim, MD, PhD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: AP-TRPV1-PII_04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO