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

Primary Purpose

Rosacea

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
Amorepacific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients aged 19 - 70 years old
  • Among the patients diagnosed with erythematotelangiectatic and papulopustular rosacea in accordance with the diagnostic criteria of the National Rosacea Society Expert Committee
  • Subjects with rosacea scored 2 or more according to the Investigator Global Assessment (IGA) at screening

Exclusion Criteria:

  • Those who can't be diagnosed or assessed for rosacea due to the presence of trauma, tattoo, scar, excessive hairs on the facial region
  • Those who have received a facial laser treatment within 6 weeks
  • Those who have been administered with oral retinoid or therapeutic vitamin A within 6 months
  • Those who have received a hormonal treatment such as estrogen within 3 months
  • Those who have been administered with systemic antibiotics or systemic steroid formulation within 4 weeks
  • Those who have been administered with local retinoid, local steroid and local antibiotics and local medication for the treatment of rosacea on face within 4 weeks
  • Those who have a history of blood disorder that can have a serious effect on the clinical study
  • Women who are pregnant, lactating or who plan to be pregnant during the clinical study period or women of childbearing potential who do not use available contraceptive methods

Sites / Locations

  • Korea University Ansan 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 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

Change in Investigator Global Assessment (IGA)
Any intragroup and intergroup differences with respect to the IGA difference value on 28th day from the baseline.

Secondary Outcome Measures

Improvement rate in Investigator Global Assessment (IGA)
Change in the erythema severity score
Rate of change in inflammatory lesion counts
Change in erythema index
Change in the telangiectasia severity score

Full Information

First Posted
September 30, 2015
Last Updated
September 19, 2016
Sponsor
Amorepacific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02583009
Brief Title
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea
Official Title
Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Anti Rosacea Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Rosacea Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (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 clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028 cream 0.1%, 0.3% and 1.0% in patients with rosacea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (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
Change in Investigator Global Assessment (IGA)
Description
Any intragroup and intergroup differences with respect to the IGA difference value on 28th day from the baseline.
Time Frame
Week 4 from the baseline
Secondary Outcome Measure Information:
Title
Improvement rate in Investigator Global Assessment (IGA)
Time Frame
Week 4 from the baseline
Title
Change in the erythema severity score
Time Frame
Week 4 from the baseline
Title
Rate of change in inflammatory lesion counts
Time Frame
Week 4 from the baseline
Title
Change in erythema index
Time Frame
Week 4 from the baseline
Title
Change in the telangiectasia severity score
Time Frame
Week 4 from the baseline

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 old Among the patients diagnosed with erythematotelangiectatic and papulopustular rosacea in accordance with the diagnostic criteria of the National Rosacea Society Expert Committee Subjects with rosacea scored 2 or more according to the Investigator Global Assessment (IGA) at screening Exclusion Criteria: Those who can't be diagnosed or assessed for rosacea due to the presence of trauma, tattoo, scar, excessive hairs on the facial region Those who have received a facial laser treatment within 6 weeks Those who have been administered with oral retinoid or therapeutic vitamin A within 6 months Those who have received a hormonal treatment such as estrogen within 3 months Those who have been administered with systemic antibiotics or systemic steroid formulation within 4 weeks Those who have been administered with local retinoid, local steroid and local antibiotics and local medication for the treatment of rosacea on face within 4 weeks Those who have a history of blood disorder that can have a serious effect on the clinical study Women who are pregnant, lactating or who plan to be pregnant during the clinical study period or women of childbearing potential who do not use available contraceptive methods
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miyoung Park, PhD
Organizational Affiliation
Amorepacific R&D Center
Official's Role
Study Director
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan si
State/Province
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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