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Study Comparing Adapalene Gel 0.3% to Differin® and Both to a Placebo Control in Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Adapalene Gel 0.3%
Differin®
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 SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
  • Subjects aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.
  • Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
  • Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

  • Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
  • Have a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients.
  • Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Adapalene Gel 0.3%

    Differin®

    Placebo

    Arm Description

    Adapalene Gel 0.3% (Taro Pharmaceuticals Inc.)

    Differin® (adapalene gel 0.3%) (Galderma Laboratories, LP, US)

    Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

    Outcomes

    Primary Outcome Measures

    Change in inflammatory lesion counts
    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
    Change in non-inflammatory lesion counts
    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

    Secondary Outcome Measures

    Clinical response of success
    The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment

    Full Information

    First Posted
    April 4, 2015
    Last Updated
    May 3, 2017
    Sponsor
    Taro Pharmaceuticals USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02411942
    Brief Title
    Study Comparing Adapalene Gel 0.3% to Differin® and Both to a Placebo Control in Treatment of Acne Vulgaris
    Official Title
    A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Adapalene Gel 0.3% to Differin® (Adapalene Gel 0.3%) and Both Active Treatments 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
    August 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    February 2015 (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
    The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).
    Detailed Description
    The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.

    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
    753 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Adapalene Gel 0.3%
    Arm Type
    Experimental
    Arm Description
    Adapalene Gel 0.3% (Taro Pharmaceuticals Inc.)
    Arm Title
    Differin®
    Arm Type
    Active Comparator
    Arm Description
    Differin® (adapalene gel 0.3%) (Galderma Laboratories, LP, US)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
    Intervention Type
    Drug
    Intervention Name(s)
    Adapalene Gel 0.3%
    Other Intervention Name(s)
    Adapalene
    Intervention Description
    Adapalene Gel 0.3% applied to the entire face once daily for 84 consecutive days
    Intervention Type
    Drug
    Intervention Name(s)
    Differin®
    Other Intervention Name(s)
    Adapalene
    Intervention Description
    Differin® applied to the entire face once daily for 84 consecutive days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Vehicle
    Intervention Description
    Placebo (vehicle of the test product) applied to the entire face once daily for 84 consecutive days
    Primary Outcome Measure Information:
    Title
    Change in inflammatory lesion counts
    Description
    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
    Time Frame
    Week 12
    Title
    Change in non-inflammatory lesion counts
    Description
    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Clinical response of success
    Description
    The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
    Time Frame
    Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. Subjects aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization. Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face. Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment. Exclusion Criteria: Female subjects who are pregnant, nursing or planning to become pregnant during study participation. Have a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
    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

    Learn more about this trial

    Study Comparing Adapalene Gel 0.3% to Differin® and Both to a Placebo Control in Treatment of Acne Vulgaris

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