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

Multi Center, Double-blind, Randomized, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Antipruritic Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Skin Pruritus Patients

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.

Study Overview

• Status: Completed
• Conditions: Skin Pruritus
• Intervention / Treatment: Drug: PAC-14028 cream 0.1%; Drug: PAC-14028 cream 0.3%; Drug: PAC-14028 cream 1.0%; Drug: PAC-14028 cream vehicle

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAC-14028 cream 0.1%; PAC-14028 cream 0.1%, Twice daily for 4 weeks	Drug: PAC-14028 cream 0.1%; Topical application
Experimental: PAC-14028 cream 0.3%; PAC-14028 cream 0.3%, Twice daily for 4 weeks	Drug: PAC-14028 cream 0.3%; Topical application
Experimental: PAC-14028 cream 1.0%; PAC-14028 cream 1.0%, Twice daily for 4 weeks	Drug: PAC-14028 cream 1.0%; Topical application
Placebo Comparator: PAC-14028 cream vehicle; PAC-14028 cream vehicle, Twice daily for 4 weeks	Drug: PAC-14028 cream vehicle; Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in intensity of pruritus as measured by 10 cm VAS	Week 4 from baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment success rate (A decrease in VAS by 2 or more is judged as a success)	Week 4 from baseline
Change in Overall Dry Skin (ODS) score	Week 4 from baseline
Change in Transepidermal Water Loss (TEWL)	Week 4 from baseline

Collaborators and Investigators

• Sponsor: Amorepacific Corporation
• Investigators: Study Director: Miyoung Park, PhD, Amorepacific R&D Center

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: AP-TRPV1_PII-02