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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amorepacific Corporation

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