Skin Pruritus
Conditions
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.
Interventions
DRUGPAC-14028
Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks
OTHERVehicle
Participants received topical Vehicle twice daily for 4 weeks
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
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Treatment success rate | Baseline through Study Day 28 |
| Change in specified symptom sum score (SRRC) Index | Baseline through Study Day 28 |
| Change in transepidermal water loss | Baseline through Study Day 28 |
| Change in skin hydration | Baseline through Study Day 28 |
Countries
South Korea
Outcome results
None listed