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A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Seborrheic Dermatitis

Primary Purpose

Seborrheic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PAC-14028 cream 0.3%
PAC-14028 cream 1.0%
PAC-14028 cream vehicle
Sponsored by
Amorepacific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrheic Dermatitis

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients aged between 19 and 65 years old
  • Clinical diagnosis of seborrheic dermatitis in the facial area with Erythema severity ≥ 2 and Scaling severity ≥ 2
  • IGE (Investigator's Global Evaluation) Score 2 or 3

Exclusion Criteria:

  • Patients with psoriasis, atopic dermatitis, facial acne, rosacea or perioral dermatitis
  • Patients who have been infected with bacteria, fungi, virus and animal infectious disease on the facial area
  • Patients who were administered topical antifungal agents, steroids, retinoids, or calcineurin suppressants for the treatment of seborrheic dermatitis within the last 2 weeks
  • Patients who were administered systemic antifungal agents, steroids, retinoids, or immunosuppressants for the treatment of seborrheic dermatitis within the last 4 weeks
  • Patients who were administered local antibiotics for the treatment of seborrheic dermatitis within the last 4 weeks
  • Pregnant women, breastfeeding women or women of childbearing potential or women who are planning a pregnancy during the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    PAC-14028 cream 0.3%

    PAC-14028 cream 1.0%

    PAC-14028 cream vehicle

    Arm Description

    Twice daily for 4 weeks

    Twice daily for 4 weeks

    Twice daily for 4 weeks

    Outcomes

    Primary Outcome Measures

    Treatment success rate in IGE(Investigator's Global Evaluation)
    Treatment success rate in IGE on 28th day from the baseline

    Secondary Outcome Measures

    Change in Erythema severity score
    Change in Scale severity score
    Change from baseline at Day 14 and 28
    Change in Visual Analogue Scale(VAS) score

    Full Information

    First Posted
    September 30, 2015
    Last Updated
    April 20, 2016
    Sponsor
    Amorepacific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02749383
    Brief Title
    A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Seborrheic Dermatitis
    Official Title
    A Randomized, Double-blind, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Seborrheic Dermatitis of the Face
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amorepacific Corporation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is a Phase II, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seborrheic Dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PAC-14028 cream 0.3%
    Arm Type
    Experimental
    Arm Description
    Twice daily for 4 weeks
    Arm Title
    PAC-14028 cream 1.0%
    Arm Type
    Experimental
    Arm Description
    Twice daily for 4 weeks
    Arm Title
    PAC-14028 cream vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    Twice daily for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    PAC-14028 cream 0.3%
    Intervention Description
    Topical application
    Intervention Type
    Drug
    Intervention Name(s)
    PAC-14028 cream 1.0%
    Intervention Description
    Topical application
    Intervention Type
    Drug
    Intervention Name(s)
    PAC-14028 cream vehicle
    Intervention Description
    Topical application
    Primary Outcome Measure Information:
    Title
    Treatment success rate in IGE(Investigator's Global Evaluation)
    Description
    Treatment success rate in IGE on 28th day from the baseline
    Time Frame
    Change from Baseline at Day 14 and Day 28
    Secondary Outcome Measure Information:
    Title
    Change in Erythema severity score
    Time Frame
    Change from baseline at Day 14 and 28
    Title
    Change in Scale severity score
    Description
    Change from baseline at Day 14 and 28
    Time Frame
    Baseline, Day 14 and Day 28
    Title
    Change in Visual Analogue Scale(VAS) score
    Time Frame
    Change from baseline at Day 14 and 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patients aged between 19 and 65 years old Clinical diagnosis of seborrheic dermatitis in the facial area with Erythema severity ≥ 2 and Scaling severity ≥ 2 IGE (Investigator's Global Evaluation) Score 2 or 3 Exclusion Criteria: Patients with psoriasis, atopic dermatitis, facial acne, rosacea or perioral dermatitis Patients who have been infected with bacteria, fungi, virus and animal infectious disease on the facial area Patients who were administered topical antifungal agents, steroids, retinoids, or calcineurin suppressants for the treatment of seborrheic dermatitis within the last 2 weeks Patients who were administered systemic antifungal agents, steroids, retinoids, or immunosuppressants for the treatment of seborrheic dermatitis within the last 4 weeks Patients who were administered local antibiotics for the treatment of seborrheic dermatitis within the last 4 weeks Pregnant women, breastfeeding women or women of childbearing potential or women who are planning a pregnancy during the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    BeomJoon Kim, Professor
    Organizational Affiliation
    Department of Dermatology, Chungang University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Seborrheic Dermatitis

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