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

Amorepacific

Status and phase: Completed; Phase 2

Conditions: Rosacea

Treatments: Drug: PAC-14028 cream 0.1%; Drug: PAC-14028 cream 1.0%; Drug: PAC-14028 cream 0.3%; Drug: PAC-14028 cream vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02583009

AP-TRPV1_PII-03

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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216 participants in 4 patient groups, including a placebo group

PAC-14028 cream 0.1%

Experimental group

Description:

PAC-14028 cream 0.1%, Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 cream 0.1%

PAC-14028 cream 0.3%

Experimental group

Description:

PAC-14028 cream 0.3%, Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 cream 0.3%

PAC-14028 cream 1.0%

Experimental group

Description:

PAC-14028 cream 1.0%, Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 cream 1.0%

PAC-14028 cream vehicle

Placebo Comparator group

Description:

PAC-14028 cream vehicle, Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 cream vehicle