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

Amorepacific

Status and phase: Completed; Phase 2

Conditions: Skin Pruritus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02565134

AP-TRPV1_PII-02

Details and patient eligibility

About

The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.

Enrollment: 296 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients aged 19 - 70 years
• Patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg)
• Patients whose result of the pruritus test (Visual Analogue Scale, VAS) at Visit 1 and 2 is 5 or more
• Patients whose overall dry skin score of the area where investigational product is applied at Visit 1 and 2 is 2 points or more

Exclusion criteria

• Patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease
• Patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases
• Patients with simple pruritus caused by such allergic material as scabies, and insect bite wound
• Patients with the symptom of systemic infection at the time of the participation in the clinical study
• Patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 weeks
• Patients with a history of taking oral steroid agent within 4 weeks
• Patients with a history of taking a physical treatment for the treatment of pruritus including phototherapy within 4 weeks
• Pregnant or breast-feeding women
• Women at a childbearing age who has childbearing potential or has a plan to get pregnant during the clinical study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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296 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