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

Skin Pruritus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565134
• Other study ID #: AP-TRPV1_PII-02
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2015
• Last updated: July 14, 2016
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pruritus
• Skin Pruritus

Intervention

Drug:
• PAC-14028 cream 0.1%
Topical application
• PAC-14028 cream 0.3%
Topical application
• PAC-14028 cream 1.0%
Topical application
• PAC-14028 cream vehicle
Topical application

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intensity of pruritus as measured by 10 cm VAS		Week 4 from baseline	No
Secondary	Treatment success rate (A decrease in VAS by 2 or more is judged as a success)		Week 4 from baseline	No
Secondary	Change in Overall Dry Skin (ODS) score		Week 4 from baseline	No
Secondary	Change in Transepidermal Water Loss (TEWL)		Week 4 from baseline	No