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

Primary Purpose

Skin Pruritus

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PAC-14028 cream 0.1%
PAC-14028 cream 0.3%
PAC-14028 cream 1.0%
PAC-14028 cream vehicle
Sponsored by
Amorepacific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Pruritus

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

PAC-14028 cream 0.1%

PAC-14028 cream 0.3%

PAC-14028 cream 1.0%

PAC-14028 cream vehicle

Arm Description

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

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

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

PAC-14028 cream vehicle, Twice daily for 4 weeks

Outcomes

Primary Outcome Measures

Change in intensity of pruritus as measured by 10 cm VAS

Secondary Outcome Measures

Treatment success rate (A decrease in VAS by 2 or more is judged as a success)
Change in Overall Dry Skin (ODS) score
Change in Transepidermal Water Loss (TEWL)

Full Information

First Posted
September 30, 2015
Last Updated
July 14, 2016
Sponsor
Amorepacific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02565134
Brief Title
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amorepacific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAC-14028 cream 0.1%
Arm Type
Experimental
Arm Description
PAC-14028 cream 0.1%, Twice daily for 4 weeks
Arm Title
PAC-14028 cream 0.3%
Arm Type
Experimental
Arm Description
PAC-14028 cream 0.3%, Twice daily for 4 weeks
Arm Title
PAC-14028 cream 1.0%
Arm Type
Experimental
Arm Description
PAC-14028 cream 1.0%, Twice daily for 4 weeks
Arm Title
PAC-14028 cream vehicle
Arm Type
Placebo Comparator
Arm Description
PAC-14028 cream vehicle, Twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
PAC-14028 cream 0.1%
Intervention Description
Topical application
Intervention Type
Drug
Intervention Name(s)
PAC-14028 cream 0.3%
Intervention Description
Topical application
Intervention Type
Drug
Intervention Name(s)
PAC-14028 cream 1.0%
Intervention Description
Topical application
Intervention Type
Drug
Intervention Name(s)
PAC-14028 cream vehicle
Intervention Description
Topical application
Primary Outcome Measure Information:
Title
Change in intensity of pruritus as measured by 10 cm VAS
Time Frame
Week 4 from baseline
Secondary Outcome Measure Information:
Title
Treatment success rate (A decrease in VAS by 2 or more is judged as a success)
Time Frame
Week 4 from baseline
Title
Change in Overall Dry Skin (ODS) score
Time Frame
Week 4 from baseline
Title
Change in Transepidermal Water Loss (TEWL)
Time Frame
Week 4 from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miyoung Park, PhD
Organizational Affiliation
Amorepacific R&D Center
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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