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

Study Overview
=================
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.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

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 | Measure Description | 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 |