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Completed

NCT Number: NCT02565134

A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus

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.

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Key information

Conditions

Skin Pruritus

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAC-14028 cream 0.1%

Drug

Topical application

PAC-14028 cream 0.3%

Drug

Topical application

PAC-14028 cream 1.0%

Drug

Topical application

PAC-14028 cream vehicle

Drug

Topical application

Primary outcomes

  1. Change in intensity of pruritus as measured by 10 cm VAS

    Time frame: Week 4 from baseline

Secondary outcomes

  1. Treatment success rate (A decrease in VAS by 2 or more is judged as a success)

    Time frame: Week 4 from baseline

  2. Change in Overall Dry Skin (ODS) score

    Time frame: Week 4 from baseline

  3. Change in Transepidermal Water Loss (TEWL)

    Time frame: Week 4 from baseline

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

Multi Center, Double-blind, Randomized, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Antipruritic Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Skin Pruritus Patients

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 1, 2015
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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