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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02583009
Other study ID # AP-TRPV1_PII-03
Secondary ID
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. completion date
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


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
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