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

Skin Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052531
• Other study ID #: AP-TRPV1_PII-01
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2014
• Last updated: September 11, 2015
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: September 2015
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

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
Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks

Other:
• Vehicle
Participants received topical Vehicle twice daily for 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	Kyu-Han Kim	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 Visual Analog Scale (VAS)	Patient reported outcome of pruritis measurement on a change in visual analog scale	Baseline through Study Day 28	No
Secondary	Treatment success rate		Baseline through Study Day 28	No
Secondary	Change in specified symptom sum score (SRRC) Index		Baseline through Study Day 28	No
Secondary	Change in transepidermal water loss		Baseline through Study Day 28	No
Secondary	Change in skin hydration		Baseline through Study Day 28	No