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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 1

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

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

24 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chung-ang University Hospital
Konkuk University Hospital
Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

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 4 weeks

PAC-14028 Cream 0.3%, Twice daily for 4 weeks

PAC-14028 Cream 1.0%, Twice daily for 4 weeks

PAC-14028 Cream Vehicle, twice daily for 4 weeks

Outcomes

Primary Outcome Measures

Success rate of Investigator's Global Assessment (IGA)

% of patients with IGA score of 0 (clear) or 1 (almost clear)

Blood concentrations of PAC-14028

Secondary Outcome Measures

Change of IGA (Investigator's Global Assessment)

Change of IGA score from baseline

Change of SCORAD (Severity Scoring of Atopic Dermatitis)

Change of SCORAD from baseline

% Change of EASI (Eczema Area and Severity Index)

Patient satisfaction measurement

Full Information

NCT ID

NCT02748993

First Posted

April 20, 2016

Last Updated

November 18, 2018

Sponsor

Amorepacific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02748993

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

September 2018 (Actual)

Study Completion Date

October 2018 (Actual)

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

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 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (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 4 weeks

Arm Title

PAC-14028 Cream 0.3%

Arm Type

Experimental

Arm Description

PAC-14028 Cream 0.3%, Twice daily for 4 weeks

Arm Title

PAC-14028 Cream 1.0%

Arm Type

Experimental

Arm Description

PAC-14028 Cream 1.0%, Twice daily for 4 weeks

Arm Title

PAC-14028 Cream Vehicle

Arm Type

Placebo Comparator

Arm Description

PAC-14028 Cream Vehicle, twice daily for 4 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

% of patients with IGA score of 0 (clear) or 1 (almost clear)

Time Frame

4 weeks

Title

Blood concentrations of PAC-14028

Description

Blood concentrations of PAC-14028

Time Frame

Day 1, Day 28

Secondary Outcome Measure Information:

Title

Change of IGA (Investigator's Global Assessment)

Description

Change of IGA score from baseline

Time Frame

1, 2, 4 week(s)

Title

Change of SCORAD (Severity Scoring of Atopic Dermatitis)

Description

Change of SCORAD from baseline

Time Frame

1, 2, 4 week(s)

Title

% Change of EASI (Eczema Area and Severity Index)

Time Frame

1, 2, 4 week(s)

Title

Patient satisfaction measurement

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Months

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyuhan Kim, MD, PhD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chung-ang University Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Konkuk University Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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