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Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)
Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)
Placebo
Sponsored by
Padagis LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

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

Inclusion Criteria:

  • Healthy men or women, 12 to 65 years of age
  • Willing to participate and sign provide written consent
  • Moderate to severe acne

Exclusion Criteria:

  • Pregnant or lactating women
  • History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin
  • Use of systemic, topical or facial products which may interfere with the study
  • Participation in any clinical study in the 30 days prior to study entry
  • Prolonged exposure to sunlight or excessive exposure to UV lights
  • Chronic use of NSAIDS

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Clindamycin 1%/Benzoyl Peroxide 5%

    Reference Product

    Vehicle

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Inflammatory Lesions
    Percent Change From Baseline in Non-inflammatory Lesions

    Secondary Outcome Measures

    Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)
    Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.

    Full Information

    First Posted
    June 4, 2010
    Last Updated
    October 11, 2021
    Sponsor
    Padagis LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01138514
    Brief Title
    Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
    Official Title
    A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    October 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Padagis LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1555 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clindamycin 1%/Benzoyl Peroxide 5%
    Arm Type
    Active Comparator
    Arm Title
    Reference Product
    Arm Type
    Active Comparator
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)
    Intervention Description
    Applied to the entire face twice daily for 10 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)
    Intervention Description
    Applied to the entire face twice daily for 10 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Inflammatory Lesions
    Time Frame
    10 weeks
    Title
    Percent Change From Baseline in Non-inflammatory Lesions
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)
    Description
    Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Healthy men or women, 12 to 65 years of age Willing to participate and sign provide written consent Moderate to severe acne Exclusion Criteria: Pregnant or lactating women History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin Use of systemic, topical or facial products which may interfere with the study Participation in any clinical study in the 30 days prior to study entry Prolonged exposure to sunlight or excessive exposure to UV lights Chronic use of NSAIDS

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels

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