Back to resultsA Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PAC-14028 cream 0.1%
PAC-14028 cream 0.3%
PAC-14028 cream 1.0%
PAC-14028 cream vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
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.
Sites / Locations
- Chung-ang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
PAC-14028 cream 0.1%
PAC-14028 cream 0.3%
PAC-14028 cream 1.0%
PAC-14028 cream vehicle
Arm Description
PAC-14028 cream 0.1%, Twice daily for 8 weeks
PAC-14028 cream 0.3%, Twice daily for 8 weeks
PAC-14028 cream 1.0%, Twice daily for 8 weeks
PAC-14028 cream vehicle, Twice daily for 8 weeks
Outcomes
Primary Outcome Measures
Success rate of Investigator's Global Assessment (IGA)
percent of patients with IGA score of 0 (clear) or 1 (almost clear)
Secondary Outcome Measures
Success rate of Investigator's Global Assessment (IGA)
percent of patients with IGA score of 0 (clear) or 1 (almost clear)
Change in SCORAD (Severity Score of Atopic Dermatitis)
% Change in Eczema Area and Severity Index (EASI)
Success rate of Pruritus Severity score
Full Information
NCT ID
NCT02757729
First Posted
April 20, 2016
Last Updated
September 19, 2016
Sponsor
Amorepacific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02757729
Brief Title
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amorepacific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAC-14028 cream 0.1%
Arm Type
Experimental
Arm Description
PAC-14028 cream 0.1%, Twice daily for 8 weeks
Arm Title
PAC-14028 cream 0.3%
Arm Type
Experimental
Arm Description
PAC-14028 cream 0.3%, Twice daily for 8 weeks
Arm Title
PAC-14028 cream 1.0%
Arm Type
Experimental
Arm Description
PAC-14028 cream 1.0%, Twice daily for 8 weeks
Arm Title
PAC-14028 cream vehicle
Arm Type
Placebo Comparator
Arm Description
PAC-14028 cream vehicle, Twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
PAC-14028 cream 0.1%
Intervention Description
Topical application
Intervention Type
Drug
Intervention Name(s)
PAC-14028 cream 0.3%
Intervention Description
Topical application
Intervention Type
Drug
Intervention Name(s)
PAC-14028 cream 1.0%
Intervention Description
Topical application
Intervention Type
Drug
Intervention Name(s)
PAC-14028 cream vehicle
Intervention Description
Topical application
Primary Outcome Measure Information:
Title
Success rate of Investigator's Global Assessment (IGA)
Description
percent of patients with IGA score of 0 (clear) or 1 (almost clear)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Success rate of Investigator's Global Assessment (IGA)
Description
percent of patients with IGA score of 0 (clear) or 1 (almost clear)
Time Frame
1, 3, 6 week(s)
Title
Change in SCORAD (Severity Score of Atopic Dermatitis)
Time Frame
1, 3, 6, 8 week(s)
Title
% Change in Eczema Area and Severity Index (EASI)
Time Frame
1, 3, 6, 8 week(s)
Title
Success rate of Pruritus Severity score
Time Frame
1, 3, 6, 8 week(s)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beomjoon Kim, MD, PhD
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-ang University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis
We'll reach out to this number within 24 hrs