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

Phase 2

Completed

• Conditions: Skin Pruritus
• Interventions: Other: Vehicle; Drug: PAC-14028

• Registration Number: NCT02052531
• Lead Sponsor: Amorepacific Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-11
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle, twice daily for 28days
PAC-14028 cream 0.3%	PAC-14028	PAC-14028 cream 0.3%, twice daily for 28 days
PAC-14028 cream 1.0%	PAC-14028	PAC-14028 cream 1.0%, twice daily for 28days

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyu-Han Kim; 🇰🇷 Seoul, Korea, Republic of