Back to results

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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

PAC-14028 cream 1.0%

PAC-14028 cream vehicle

Elidel cream 1%

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients aged between 20 and 65 years old
Patients with atopic dermatitis, diagnosed according to Hanifin and Rajka diagnostic criteria
SCORAD (SCORing Atopic Dermatitis) Score less than 40

Exclusion Criteria:

Patients presenting symptoms of systemic infection at screening
Patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration
Patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration
Pregnant women or breastfeeding women
Women of childbearing potential or women who are planning a pregnancy during the study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

PAC-14028 cream 1.0%

PAC-14028 cream vehicle

Elidel cream 1%

Arm Description

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

PAC-14028 cream vehicle, Twice daily for 4 weeks

Elidel cream 1%, Twice daily for 4 weeks

Outcomes

Primary Outcome Measures

SCORing Atopic Dermatitis (SCORAD) index

Secondary Outcome Measures

Visual Analogue Scale (VAS) score

Success rate to pruritus treatment

Eczema Area and Severity Index (EASI) score

Each SCORAD index

Transepidermal Water Loss (TEWL) level

Skin Hydration level

Skin hydration was measured using the Corneometer

Full Information

NCT ID

NCT02583022

First Posted

September 30, 2015

Last Updated

October 20, 2015

Sponsor

Amorepacific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02583022

Brief Title

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

Official Title

A Randomized, Open-label, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

August 2015 (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

The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 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

None (Open Label)

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

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

Arm Title

Elidel cream 1%

Arm Type

Active Comparator

Arm Description

Elidel cream 1%, Twice daily for 4 weeks

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

Intervention Type

Drug

Intervention Name(s)

Elidel cream 1%

Intervention Description

Topical application

Primary Outcome Measure Information:

Title

SCORing Atopic Dermatitis (SCORAD) index

Time Frame

Change from baseline at Day 28

Secondary Outcome Measure Information:

Title

Visual Analogue Scale (VAS) score

Time Frame