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

NCT02052531 | Completed Phase 2 DMC

• 1 other identifier: AP-TRPV1_PII-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Pruritus

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale (VAS)

  Patient reported outcome of pruritis measurement on a change in visual analog scale

  Baseline through Study Day 28

Secondary Outcomes (4)

• 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

Study Arms (3)

PAC-14028 cream 0.3%

EXPERIMENTAL

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

Drug: PAC-14028

PAC-14028 cream 1.0%

EXPERIMENTAL

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

Drug: PAC-14028

Vehicle

PLACEBO COMPARATOR

Vehicle, twice daily for 28days

Other: Vehicle

Interventions

PAC-14028 DRUG

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

Also known as: PAC-14028 Cream 0.3%, PAC-14028 Cream 1.0%

PAC-14028 cream 0.3%; PAC-14028 cream 1.0%

Vehicle OTHER

Participants received topical Vehicle twice daily for 4 weeks

Also known as: Vehicle of PAC-14028 Cream

Vehicle

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amorepacific Corporation: lead

Study Sites (1)

Kyu-Han Kim

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

N-(1-(3,5-difluoro-4-methanesulfonylaminophenyl)ethyl)-3-(2-propyl-6-trifluoromethylpyridine-3-yl)acrylamide

Study Officials

• Kyu-Han Kim, MD,Ph.D

  Department of Dermatology, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 3, 2014
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 14, 2015

Record last verified: 2015-09

Locations

KR (1)