Evaluation of the Antipruritic Effect of PAC-14028 Cream in Skin Pruritus

A Phase II, Single Center, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of PAC-14028 Cream in Dermal Pruritus

The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific Corporation in patients with dermal pruritus.

Study Overview

• Status: Completed
• Conditions: Skin Pruritus
• Intervention / Treatment: Drug: PAC-14028; Other: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Kyu-Han Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients at the age of 20 to 65 years old (both inclusive)
• Pruritus test ≥ 5cm (10cm Visual Analogue Scale [VAS]) at baseline
• Eczema or dry skin on the study drug application site
• Women of childbearing potential should have a negative urine pregnancy test at screening and agree to employ an effective method of birth control (surgical sterilization or oral contraceptives, barrier method with spermicides, intrauterine device, etc.) during the study period.
• Voluntarily signed written informed consent forms for study participation.

Exclusion Criteria:

• Pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease.
• Chronic skin diseases such as malignant tumor or chronic urticaria, among skin diseases.
• Simple pruritus caused by allergic substances such as scabies or insect bites.
• Presence of symptoms of generalized infection at the time of study participation.
• Previous local treatment or antibiotics administration for pruritus within 7 days prior to study participation.
• Previous use of oral steroids within 1 month and local steroids within 2 weeks prior to study participation.
• History of physical treatment for pruritus, including phototherapy, within 1 month prior to study participation.
• Patients who are treated with prohibited concomitant drugs or considered to inevitably require treatment with prohibited concomitant drugs during the study period.
• Renal function impairment with creatinine level
• Hepatic function impairment with aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)
• Pregnant and lactating women
• Participation in another clinical study within 1 month prior to screening.
• Patients considered ineligible for study participation by the principal investigator or sub-investigator for other reasons; pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PAC-14028 cream 0.3%; PAC-14028 cream 0.3%, twice daily for 28 days	Drug: PAC-14028; Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks; Other Names: PAC-14028 Cream 1.0%; PAC-14028 Cream 0.3%
EXPERIMENTAL: PAC-14028 cream 1.0%; PAC-14028 cream 1.0%, twice daily for 28days	Drug: PAC-14028; Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks; Other Names: PAC-14028 Cream 1.0%; PAC-14028 Cream 0.3%
PLACEBO_COMPARATOR: Vehicle; Vehicle, twice daily for 28days	Other: Vehicle; Participants received topical Vehicle twice daily for 4 weeks; Other Names: Vehicle of PAC-14028 Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS)	Patient reported outcome of pruritis measurement on a change in visual analog scale	Baseline through Study Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment success rate	Baseline through Study Day 28
Change in specified symptom sum score (SRRC) Index	Baseline through Study Day 28
Change in transepidermal water loss	Baseline through Study Day 28
Change in skin hydration	Baseline through Study Day 28

Collaborators and Investigators

• Sponsor: Amorepacific Corporation
• Investigators: Principal Investigator: Kyu-Han Kim, MD,Ph.D, Department of Dermatology, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (ESTIMATE): February 3, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: AP-TRPV1_PII-01