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

Phase 2

Completed

• Conditions: Skin Pruritus
• Interventions: Drug: PAC-14028 cream 0.1%; Drug: PAC-14028 cream 0.3%; Drug: PAC-14028 cream 1.0%; Drug: PAC-14028 cream vehicle

• Registration Number: NCT02565134
• Lead Sponsor: Amorepacific Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Primary Completion: 2016-06
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-14
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAC-14028 cream 0.1%	PAC-14028 cream 0.1%	PAC-14028 cream 0.1%, Twice daily for 4 weeks
PAC-14028 cream 0.3%	PAC-14028 cream 0.3%	PAC-14028 cream 0.3%, Twice daily for 4 weeks
PAC-14028 cream 1.0%	PAC-14028 cream 1.0%	PAC-14028 cream 1.0%, Twice daily for 4 weeks
PAC-14028 cream vehicle	PAC-14028 cream vehicle	PAC-14028 cream vehicle, Twice daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in intensity of pruritus as measured by 10 cm VAS	Week 4 from baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of