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

NCT02565134 | Completed Phase 2 DMC

• 1 other identifier: AP-TRPV1_PII-02
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Pruritus

Outcome Measures

Primary Outcomes (1)

• Change in intensity of pruritus as measured by 10 cm VAS

  Week 4 from baseline

Secondary Outcomes (3)

• 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

Study Arms (4)

PAC-14028 cream 0.1%

EXPERIMENTAL

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

Drug: PAC-14028 cream 0.1%

PAC-14028 cream 0.3%

EXPERIMENTAL

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

Drug: PAC-14028 cream 0.3%

PAC-14028 cream 1.0%

EXPERIMENTAL

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

Drug: PAC-14028 cream 1.0%

PAC-14028 cream vehicle

PLACEBO COMPARATOR

PAC-14028 cream vehicle, Twice daily for 4 weeks

Drug: PAC-14028 cream vehicle

Interventions

PAC-14028 cream 0.1% DRUG

Topical application

PAC-14028 cream 0.1%

PAC-14028 cream 0.3% DRUG

Topical application

PAC-14028 cream 0.3%

PAC-14028 cream 1.0% DRUG

Topical application

PAC-14028 cream 1.0%

PAC-14028 cream vehicle DRUG

Topical application

PAC-14028 cream vehicle

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amorepacific Corporation: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Officials

• Miyoung Park, PhD

  Amorepacific R&D Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 1, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 15, 2016

Record last verified: 2016-07

Locations

KR (1)