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Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Test.
Aczone Gel 5%
Placebo
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris
  • Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below)

Exclusion Criteria:

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Test Gel 5%

    ACZONE Gel 5%

    Placebo Gel

    Arm Description

    Topical, twice daily on the face for 84 days.

    Topical, twice daily on the face for 84 days

    Topical, twice daily on the face for 84 days

    Outcomes

    Primary Outcome Measures

    Change in inflammatory lesion count
    Change in non-inflammatory lesion count

    Secondary Outcome Measures

    Full Information

    First Posted
    October 8, 2016
    Last Updated
    May 3, 2017
    Sponsor
    Taro Pharmaceuticals USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02929719
    Brief Title
    Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
    Official Title
    A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Test Gel, 5% to ACZONE Gel, 5% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taro Pharmaceuticals USA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Therapeutic equivalence and safety study
    Detailed Description
    To evaluate the therapeutic equivalence and safety of Test formulation and marketed Reference Listed Drug (RLD). To demonstrate the superiority of efficacy of the Test and Reference products over the placebo control in the treatment. To compare the safety of Test, Reference and Placebo treatments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acne Vulgaris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1134 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test Gel 5%
    Arm Type
    Experimental
    Arm Description
    Topical, twice daily on the face for 84 days.
    Arm Title
    ACZONE Gel 5%
    Arm Type
    Active Comparator
    Arm Description
    Topical, twice daily on the face for 84 days
    Arm Title
    Placebo Gel
    Arm Type
    Placebo Comparator
    Arm Description
    Topical, twice daily on the face for 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Test.
    Other Intervention Name(s)
    dapsone
    Intervention Description
    gel
    Intervention Type
    Drug
    Intervention Name(s)
    Aczone Gel 5%
    Other Intervention Name(s)
    dapsone
    Intervention Description
    gel
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Vehicle
    Intervention Description
    gel
    Primary Outcome Measure Information:
    Title
    Change in inflammatory lesion count
    Time Frame
    baseline to week 12 (study day 84)
    Title
    Change in non-inflammatory lesion count
    Time Frame
    baseline to week 12 (study day 84)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below) Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catawba Research
    Organizational Affiliation
    http://catawbaresearch.com/contact/
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

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