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

Amorepacific

Status and phase: Completed; Phase 2

Conditions: Skin Pruritus

Treatments: Other: Vehicle; Drug: PAC-14028

Study type: Interventional

Funder types: Industry

Identifiers

NCT02052531

AP-TRPV1_PII-01

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 3 patient groups, including a placebo group

PAC-14028 cream 0.3%

Experimental group

Description:

PAC-14028 cream 0.3%, twice daily for 28 days

Treatment:

Drug: PAC-14028

PAC-14028 cream 1.0%

Experimental group

Description:

PAC-14028 cream 1.0%, twice daily for 28days

Treatment:

Drug: PAC-14028

Vehicle

Placebo Comparator group

Description:

Vehicle, twice daily for 28days

Treatment:

Other: Vehicle