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An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Dapsone Formulation A
Dapsone Formulation B
Dapsone Formulation C
Dapsone 5% Gel
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participation in Allergan study 225678-004

Exclusion Criteria:

  • Anticipates the need for surgery or hospitalization during the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Dapsone Formulation A

    Dapsone Formulation B

    Dapsone Formulation C

    Dapsone 5% Gel

    Arm Description

    Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

    Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

    Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

    Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Inflammatory Lesion Count

    Secondary Outcome Measures

    Change from Baseline in Non-Inflammatory Lesion Count
    Change from Baseline in Total Lesion Count
    Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1

    Full Information

    First Posted
    February 5, 2013
    Last Updated
    February 22, 2013
    Sponsor
    Allergan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01785836
    Brief Title
    An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was never initiated due to company decision. No study subjects were ever enrolled or dosed.
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    October 2013 (Anticipated)
    Study Completion Date
    October 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Allergan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.

    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
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dapsone Formulation A
    Arm Type
    Experimental
    Arm Description
    Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
    Arm Title
    Dapsone Formulation B
    Arm Type
    Experimental
    Arm Description
    Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
    Arm Title
    Dapsone Formulation C
    Arm Type
    Experimental
    Arm Description
    Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
    Arm Title
    Dapsone 5% Gel
    Arm Type
    Active Comparator
    Arm Description
    Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Dapsone Formulation A
    Intervention Description
    Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Dapsone Formulation B
    Intervention Description
    Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Dapsone Formulation C
    Intervention Description
    Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Dapsone 5% Gel
    Other Intervention Name(s)
    ACZONE®
    Intervention Description
    Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Inflammatory Lesion Count
    Time Frame
    Baseline, Week 12
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in Non-Inflammatory Lesion Count
    Time Frame
    Baseline, Week 12
    Title
    Change from Baseline in Total Lesion Count
    Time Frame
    Baseline, Week 12
    Title
    Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1
    Time Frame
    Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participation in Allergan study 225678-004 Exclusion Criteria: Anticipates the need for surgery or hospitalization during the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Allergan
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris

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