Rosacea
Conditions
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.
Interventions
Topical application
Topical application
Topical application
Topical application
Sponsors
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Investigator Global Assessment (IGA) | Week 4 from the baseline | Any intragroup and intergroup differences with respect to the IGA difference value on 28th day from the baseline. |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed