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

Phase 2

Completed

• Conditions: Rosacea
• Interventions: Drug: PAC-14028 cream vehicle; Drug: PAC-14028 cream 0.1%; Drug: PAC-14028 cream 0.3%; Drug: PAC-14028 cream 1.0%

• Registration Number: NCT02583009
• Lead Sponsor: Amorepacific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Primary Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAC-14028 cream vehicle	PAC-14028 cream vehicle	PAC-14028 cream vehicle, Twice daily for 4 weeks
PAC-14028 cream 0.1%	PAC-14028 cream 0.1%	PAC-14028 cream 0.1%, Twice daily for 4 weeks
PAC-14028 cream 0.3%	PAC-14028 cream 0.3%	PAC-14028 cream 0.3%, Twice daily for 4 weeks
PAC-14028 cream 1.0%	PAC-14028 cream 1.0%	PAC-14028 cream 1.0%, Twice daily for 4 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Korea University Ansan Hospital; 🇰🇷 Ansan si, Gyeonggi-do, Korea, Republic of