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

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583009
• Other study ID #: AP-TRPV1_PII-03
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2015
• Last updated: September 19, 2016
• Start date: October 2014

Study information

• Verified date: September 2016
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• PAC-14028 cream 0.1%
Topical application
• PAC-14028 cream 0.3%
Topical application
• PAC-14028 cream 1.0%
Topical application
• PAC-14028 cream vehicle
Topical application

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Improvement rate in Investigator Global Assessment (IGA)		Week 4 from the baseline	No
Secondary	Change in the erythema severity score		Week 4 from the baseline	No
Secondary	Rate of change in inflammatory lesion counts		Week 4 from the baseline	No
Secondary	Change in erythema index		Week 4 from the baseline	No
Secondary	Change in the telangiectasia severity score		Week 4 from the baseline	No