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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: PAC-14028 cream 0.1%; Drug: PAC-14028 cream vehicle; Drug: PAC-14028 cream 0.3%; Drug: PAC-14028 cream 1.0%

• Registration Number: NCT02757729
• Lead Sponsor: Amorepacific Corporation

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-02
• Primary Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAC-14028 cream 0.1%	PAC-14028 cream 0.1%	PAC-14028 cream 0.1%, Twice daily for 8 weeks
PAC-14028 cream vehicle	PAC-14028 cream vehicle	PAC-14028 cream vehicle, Twice daily for 8 weeks
PAC-14028 cream 0.3%	PAC-14028 cream 0.3%	PAC-14028 cream 0.3%, Twice daily for 8 weeks
PAC-14028 cream 1.0%	PAC-14028 cream 1.0%	PAC-14028 cream 1.0%, Twice daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Success rate of Investigator's Global Assessment (IGA)	8 weeks	percent of patients with IGA score of 0 (clear) or 1 (almost clear)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chung-ang University Hospital; 🇰🇷 Seoul, Korea, Republic of