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

A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis

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

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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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 4 weeks	Drug: PAC-14028 Cream 0.1%; Topical application
Experimental: PAC-14028 Cream 0.3%; PAC-14028 Cream 0.3%, Twice daily for 4 weeks	Drug: PAC-14028 Cream 0.3%; Topical application
Experimental: PAC-14028 Cream 1.0%; PAC-14028 Cream 1.0%, Twice daily for 4 weeks	Drug: PAC-14028 Cream 1.0%; Topical application
Placebo Comparator: PAC-14028 Cream Vehicle; PAC-14028 Cream Vehicle, twice daily for 4 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)	% of patients with IGA score of 0 (clear) or 1 (almost clear)	4 weeks
Blood concentrations of PAC-14028	Blood concentrations of PAC-14028	Day 1, Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of IGA (Investigator's Global Assessment)	Change of IGA score from baseline	1, 2, 4 week(s)
Change of SCORAD (Severity Scoring of Atopic Dermatitis)	Change of SCORAD from baseline	1, 2, 4 week(s)
% Change of EASI (Eczema Area and Severity Index)		1, 2, 4 week(s)
Patient satisfaction measurement		4 weeks

Collaborators and Investigators

• Sponsor: Amorepacific Corporation

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 18, 2018
• Last Verified: November 1, 2018

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-05

Plan for Individual participant data (IPD)

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