CClinicalTrials.gg
Sign In
CompletedNCT02565134Updated Jul 15, 2016

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

A Phase 2 interventional study of PAC-14028 cream 0.1% and PAC-14028 cream 0.3% in Skin Pruritus, sponsored by Amorepacific Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-07-15.

Sponsored by Amorepacific Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
296
Allocation
Randomized
Ages
19 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Pruritus

Browse trials for

03

In context

Pruritus

354 studies on the registry are indexed under Pruritus; 74 are open to participants now.

This study's enrollment of 296 is above the median of 60 across 294 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

Amorepacific Corporation is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
296 participants (actual)

Study arms

  • Experimental
    PAC-14028 cream 0.1%

    PAC-14028 cream 0.1%, Twice daily for 4 weeks

    Drug: PAC-14028 cream 0.1%

  • Experimental
    PAC-14028 cream 0.3%

    PAC-14028 cream 0.3%, Twice daily for 4 weeks

    Drug: PAC-14028 cream 0.3%

  • Experimental
    PAC-14028 cream 1.0%

    PAC-14028 cream 1.0%, Twice daily for 4 weeks

    Drug: PAC-14028 cream 1.0%

  • Placebo comparator
    PAC-14028 cream vehicle

    PAC-14028 cream vehicle, Twice daily for 4 weeks

    Drug: PAC-14028 cream vehicle

Interventions

  • DrugPAC-14028 cream 0.1%

    Topical application

  • DrugPAC-14028 cream 0.3%

    Topical application

  • DrugPAC-14028 cream 1.0%

    Topical application

  • DrugPAC-14028 cream vehicle

    Topical application

06

What researchers measure

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

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02565134
Lead sponsor
Amorepacific Corporation
Responsible party
Sponsor
First posted
Oct 1, 2015
Start date
Oct 2014
Primary completion
Jun 2016
Completion
Jul 2016
Last update
Jul 15, 2016

Study contacts

Miyoung Park, PhD
study director · Amorepacific R&D Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pruritus→

Other studies from this sponsor

Amorepacific Corporation

Start the discussion