Skin Pruritus
Conditions
Brief summary
The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.
Interventions
Topical application
Topical application
Topical application
Topical application
Sponsors
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients aged 19 - 70 years * Patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg) * Patients whose result of the pruritus test (Visual Analogue Scale, VAS) at Visit 1 and 2 is 5 or more * Patients whose overall dry skin score of the area where investigational product is applied at Visit 1 and 2 is 2 points or more
Exclusion criteria
* Patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease * Patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases * Patients with simple pruritus caused by such allergic material as scabies, and insect bite wound * Patients with the symptom of systemic infection at the time of the participation in the clinical study * Patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 weeks * Patients with a history of taking oral steroid agent within 4 weeks * Patients with a history of taking a physical treatment for the treatment of pruritus including phototherapy within 4 weeks * Pregnant or breast-feeding women * Women at a childbearing age who has childbearing potential or has a plan to get pregnant during the clinical study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in intensity of pruritus as measured by 10 cm VAS | Week 4 from baseline |
Secondary
| Measure | Time frame |
|---|---|
| Treatment success rate (A decrease in VAS by 2 or more is judged as a success) | Week 4 from baseline |
| Change in Overall Dry Skin (ODS) score | Week 4 from baseline |
| Change in Transepidermal Water Loss (TEWL) | Week 4 from baseline |
Countries
South Korea
Outcome results
None listed