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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Placebo
Sponsored by
Padagis LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, bioequivalency, clindamycin, benzoyl peroxide

Eligibility Criteria

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

Inclusion Criteria:

  • healthy men or women, 12 years of age and older
  • willing to participate and sign a copy of the informed consent form
  • moderate to severe facial acne

Exclusion Criteria:

  • history of allergy or hypersensitivity to clindamycin or benzoyl peroxide
  • pregnant or lactating women
  • evidence of a clinically significant disorder
  • receipt of any drugs as part of a research study within 30 days prior to study dosing
  • use of systemic, topical or facial products which may interfere with study
  • significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    1% Clindamycin/5% Benzoyl Peroxide Topical Gel

    DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel

    Placebo

    Arm Description

    Test product

    Reference product

    Outcomes

    Primary Outcome Measures

    Reduction of Inflammatory Lesions
    The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).

    Secondary Outcome Measures

    Full Information

    First Posted
    January 4, 2010
    Last Updated
    July 7, 2023
    Sponsor
    Padagis LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01044264
    Brief Title
    Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations
    Official Title
    A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations in the Treatment of Moderate to Severe Acne Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    September 2008 (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
    A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acne Vulgaris
    Keywords
    Acne Vulgaris, bioequivalency, clindamycin, benzoyl peroxide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    602 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1% Clindamycin/5% Benzoyl Peroxide Topical Gel
    Arm Type
    Active Comparator
    Arm Description
    Test product
    Arm Title
    DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
    Arm Type
    Active Comparator
    Arm Description
    Reference product
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    1% Clindamycin/5% Benzoyl Peroxide Topical Gel
    Other Intervention Name(s)
    DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
    Intervention Description
    Topical Gel
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Reduction of Inflammatory Lesions
    Description
    The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
    Time Frame
    Baseline and week 11

    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 men or women, 12 years of age and older willing to participate and sign a copy of the informed consent form moderate to severe facial acne Exclusion Criteria: history of allergy or hypersensitivity to clindamycin or benzoyl peroxide pregnant or lactating women evidence of a clinically significant disorder receipt of any drugs as part of a research study within 30 days prior to study dosing use of systemic, topical or facial products which may interfere with study significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn

    12. IPD Sharing Statement

    Learn more about this trial

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

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