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Efficacy Study in Patients With Acne Vulgaris.

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ADPS topical product
Placebo Control
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

9 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male or non pregnant female aged ≥ 9 years with a clinical diagnosis of acne vulgaris

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 Type

    Experimental

    Placebo Comparator

    Arm Label

    ADPS topical product

    Placebo Control

    Arm Description

    A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

    A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
    Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face
    The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.
    Success was defined as an IGA score that was at least two grades less than the baseline assessment.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2016
    Last Updated
    September 21, 2018
    Sponsor
    Taro Pharmaceuticals USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02935036
    Brief Title
    Efficacy Study in Patients With Acne Vulgaris.
    Official Title
    A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study to Evaluate the Efficacy and Safety of ADPS in the Treatment of Acne Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 3, 2016 (Actual)
    Primary Completion Date
    January 24, 2017 (Actual)
    Study Completion Date
    March 21, 2017 (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
    Safety and efficacy study in patients with acne vulgaris
    Detailed Description
    randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS in the treatment of acne vulgaris.

    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 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    294 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ADPS topical product
    Arm Type
    Experimental
    Arm Description
    A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
    Arm Title
    Placebo Control
    Arm Type
    Placebo Comparator
    Arm Description
    A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    ADPS topical product
    Other Intervention Name(s)
    Active
    Intervention Description
    topical product
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Control
    Other Intervention Name(s)
    vehicle
    Intervention Description
    topical product
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
    Time Frame
    Baseline to week 12 (study day 84)
    Title
    Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face
    Time Frame
    Baseline to week 12 (study day 84)
    Title
    The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.
    Description
    Success was defined as an IGA score that was at least two grades less than the baseline assessment.
    Time Frame
    Baseline to Week 12 (study day 84)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male or non pregnant female aged ≥ 9 years with a clinical diagnosis of acne vulgaris 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

    Efficacy Study in Patients With Acne Vulgaris.

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