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A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%
Onexton™ Gel
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.
  • Must have a minimum ≥ 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.
  • A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
  • A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Clindamycin and BPO Gel 1.2%/3.75%

    Onexton™ Gel

    Placebo

    Arm Description

    Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days.

    Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.

    Placebo (vehicle of the test product) applied to the face once daily for 84 days.

    Outcomes

    Primary Outcome Measures

    Demonstration of Bioequivalence
    Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts

    Secondary Outcome Measures

    Clinical response of success
    The proportion of subjects with a clinical response of success at week 12 defined as an Investigator's Global Assessment score that is at least 2 grades less than the baseline assessment.

    Full Information

    First Posted
    October 14, 2015
    Last Updated
    May 16, 2018
    Sponsor
    Taro Pharmaceuticals USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02578043
    Brief Title
    A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris
    Official Title
    A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objectives of this study are to evaluate the therapeutic equivalence and safety.
    Detailed Description
    The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.

    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
    844 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clindamycin and BPO Gel 1.2%/3.75%
    Arm Type
    Experimental
    Arm Description
    Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days.
    Arm Title
    Onexton™ Gel
    Arm Type
    Active Comparator
    Arm Description
    Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo (vehicle of the test product) applied to the face once daily for 84 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%
    Other Intervention Name(s)
    Clindamycin, BPO
    Intervention Description
    Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)
    Intervention Type
    Drug
    Intervention Name(s)
    Onexton™ Gel
    Other Intervention Name(s)
    Clindamycin, BPO
    Intervention Description
    Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Vehicle
    Intervention Description
    Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
    Primary Outcome Measure Information:
    Title
    Demonstration of Bioequivalence
    Description
    Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory 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 defined as an Investigator's Global Assessment score that is at least 2 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. Must have a minimum ≥ 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. A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis. A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.
    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

    A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris

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