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Dalacin-T Gel Post Approval Study

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
clindamycin
nadifloxacin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

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

Inclusion Criteria: Acne vulgaris patients found by a investigator to have at least 10 inflammatory lesions (papules, pustules) on a portion of either a cheeks or the forehead, with an inflammation severity of moderate or worse. Exclusion Criteria: Patients with, for example, acne elastosis, steroidal acne, necrotizing acne, or occupational acne.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of investigator) at Treatment Week 4 or EOT (discontinuation)

    Secondary Outcome Measures

    To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of the Data Review Committee based on photographs) at Treatment Week 4 or EOT (discontinuation) According

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    May 9, 2011
    Sponsor
    Pfizer
    Collaborators
    Parexel, SACT INTERNATIONAL Co., LTD., Acronet, Bellsystem24 , Inc., Mitsubishi Kagaku Bio-Clinical Laboratories, inc, SATO Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00219570
    Brief Title
    Dalacin-T Gel Post Approval Study
    Official Title
    Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer
    Collaborators
    Parexel, SACT INTERNATIONAL Co., LTD., Acronet, Bellsystem24 , Inc., Mitsubishi Kagaku Bio-Clinical Laboratories, inc, SATO Pharmaceutical Co., Ltd.

    4. Oversight

    5. Study Description

    Brief Summary
    To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of Dalacin T 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 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    134 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    clindamycin
    Intervention Type
    Drug
    Intervention Name(s)
    nadifloxacin
    Primary Outcome Measure Information:
    Title
    To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of investigator) at Treatment Week 4 or EOT (discontinuation)
    Secondary Outcome Measure Information:
    Title
    To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of the Data Review Committee based on photographs) at Treatment Week 4 or EOT (discontinuation) According

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Acne vulgaris patients found by a investigator to have at least 10 inflammatory lesions (papules, pustules) on a portion of either a cheeks or the forehead, with an inflammation severity of moderate or worse. Exclusion Criteria: Patients with, for example, acne elastosis, steroidal acne, necrotizing acne, or occupational acne.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Dalacin-T Gel Post Approval Study

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