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Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT00834210
Collaborator
(none)
171
Enrollment
1
Location
2
Arms
9
Duration (Months)
19
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe facial acne vulgaris

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
171 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Dapsone Gel 5% and Tazarotene Cream 0.1%

Drug: Dapsone
Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks
Other Names:
  • Aczone Gel 5%; Tazorac Cream 0.1%

    		•
    Active Comparator: 2

    Tazarotene Cream 0.1%

    Drug: Tazarotene
    Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks
    Other Names:
  • Tazorac Cream 0.1%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12 [Baseline, Week 12]

      Change from baseline in inflammatory lesion count (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).

    Secondary Outcome Measures

    1. Change From Baseline in Investigator Global Assessment at Week 12 [Baseline, Week 12]

      Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).

    2. Change From Baseline in Overall Disease Severity at Week 12 [Baseline, Week 12]

      Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).

    3. Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 [Baseline, Week 12]

      Change from baseline in non-inflammatory lesion counts(open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Facial acne vulgaris characterized by the following: 30-100 facial inflammatory lesions; and 25-100 facial non-inflammatory lesions; stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or more nodules and/or cysts (diameter of 1cm or greater). Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study
    Exclusion Criteria:
    • Non-compliance with washout period; history of clinically significant anemia or hemolysis; skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris; allergy or sensitivity to any component of the test medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fremont California United States

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT00834210
    Other Study ID Numbers:
    • MA-ACZ0802
    First Posted:
    Feb 3, 2009
    Last Update Posted:
    Oct 31, 2011
    Last Verified:
    Sep 1, 2011
    Additional relevant MeSH terms:
    Acne Vulgaris
    Nicotinic Acids
    Dapsone
    Tazarotene

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Arm/Group Description Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Period Title: Overall Study
    STARTED 86 85
    COMPLETED 83 77
    NOT COMPLETED 3 8

    Baseline Characteristics

    Arm/Group Title Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1% Total
    Arm/Group Description Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1% Total of all reporting groups
    Overall Participants 86 85 171
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    17.8
    16.7
    17.2
    Sex: Female, Male (Count of Participants)
    Female
    48
    55.8%
    36
    42.4%
    84
    49.1%
    Male
    38
    44.2%
    49
    57.6%
    87
    50.9%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12
    Description Change from baseline in inflammatory lesion count (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT), which included all patients who started the study (randomized).
    Arm/Group Title Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Arm/Group Description Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Measure Participants 86 85
    Baseline
    38.94
    (11.67)
    40.78
    (12.85)
    Week 12
    -25.77
    (11.23)
    -24.82
    (14.06)
    2. Secondary Outcome
    Title Change From Baseline in Investigator Global Assessment at Week 12
    Description Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT), which included all patients who started the study (randomized)
    Arm/Group Title Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Arm/Group Description Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Measure Participants 86 85
    Baseline
    2.93
    (0.37)
    3.04
    (0.36)
    Week 12
    -1.07
    (0.96)
    -0.96
    (0.73)
    3. Secondary Outcome
    Title Change From Baseline in Overall Disease Severity at Week 12
    Description Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT), which included all patients who started the study (randomized).
    Arm/Group Title Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Arm/Group Description Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Measure Participants 86 85
    Baseline
    4.03
    (0.73)
    4.08
    (0.69)
    Week 12
    -1.93
    (1.11)
    -1.63
    (1.08)
    4. Secondary Outcome
    Title Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
    Description Change from baseline in non-inflammatory lesion counts(open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT), which included all patients who started the study (randomized).
    Arm/Group Title Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Arm/Group Description Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Measure Participants 86 85
    Baseline
    46.42
    (17.40)
    46.48
    (16.86)
    Week 12
    -26.73
    (15.08)
    -21.74
    (18.15)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Arm/Group Description Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    All Cause Mortality
    Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/86 (0%) 0/85 (0%)
    Other (Not Including Serious) Adverse Events
    Dapsone Gel 5% and Tazarotene Cream 0.1% Tazarotene Cream 0.1%
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/86 (9.3%) 5/85 (5.9%)
    Infections and infestations
    Cold 8/86 (9.3%) 5/85 (5.9%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo

    Results Point of Contact

    Name/Title Vice President, Medical Affairs
    Organization Allergan, Inc.
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT00834210
    Other Study ID Numbers:
    • MA-ACZ0802
    First Posted:
    Feb 3, 2009
    Last Update Posted:
    Oct 31, 2011
    Last Verified:
    Sep 1, 2011