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

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

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.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: PAC-14028 cream 0.1%; Drug: PAC-14028 cream 0.3%; Drug: PAC-14028 cream 1.0%; Drug: PAC-14028 cream vehicle

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Ansan si, Gyeonggi-do, Korea, Republic of
      • Korea University Ansan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAC-14028 cream 0.1%; PAC-14028 cream 0.1%, Twice daily for 4 weeks	Drug: PAC-14028 cream 0.1%; Topical application
Experimental: PAC-14028 cream 0.3%; PAC-14028 cream 0.3%, Twice daily for 4 weeks	Drug: PAC-14028 cream 0.3%; Topical application
Experimental: PAC-14028 cream 1.0%; PAC-14028 cream 1.0%, Twice daily for 4 weeks	Drug: PAC-14028 cream 1.0%; Topical application
Placebo Comparator: PAC-14028 cream vehicle; PAC-14028 cream vehicle, Twice daily for 4 weeks	Drug: PAC-14028 cream vehicle; Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Investigator Global Assessment (IGA)	Any intragroup and intergroup differences with respect to the IGA difference value on 28th day from the baseline.	Week 4 from the baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement rate in Investigator Global Assessment (IGA)	Week 4 from the baseline
Change in the erythema severity score	Week 4 from the baseline
Rate of change in inflammatory lesion counts	Week 4 from the baseline
Change in erythema index	Week 4 from the baseline
Change in the telangiectasia severity score	Week 4 from the baseline

Collaborators and Investigators

• Sponsor: Amorepacific Corporation
• Investigators: Study Director: Miyoung Park, PhD, Amorepacific R&D Center

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: AP-TRPV1_PII-03