Clinical trial NCT02052531: Evaluation of the Antipruritic Effect of PAC-14028 Cream in Skin Pruritus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Pruritus
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS)
timeFrame: Baseline through Study Day 28
Secondary outcomes:
measure: Treatment success rate
timeFrame: Baseline through Study Day 28
measure: Change in specified symptom sum score (SRRC) Index
timeFrame: Baseline through Study Day 28
measure: Change in transepidermal water loss
timeFrame: Baseline through Study Day 28
measure: Change in skin hydration
timeFrame: Baseline through Study Day 28
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyu-Han Kim
Study officials:
affiliation: Department of Dermatology, Seoul National University Hospital
name: Kyu-Han Kim, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: