Multi center, double-blind, randomized, placebo controlled parallel-group clinical trial to evaluate antirosacea effect and safety of PAC-14028 cream in rosacea patients
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0001705
- Lead Sponsor
- AmorePacific
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 216
•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
•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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Investigator Global Assessment
- Secondary Outcome Measures
Name Time Method Change in the erythema severity;Rate of change in inflammatory lesion counts ;Change in erythema index;Change in the telangiectasia severity