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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Ansan Hospital | Ansan si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Amorepacific Corporation |
Korea, Republic of,
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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