Last updated: 03/05/2020 21:00:20
Marketing Authorization of “Duac® Gel” in Japan was transferred to POLA Pharma.

DUAC Drug Use Investigation

GSK study ID
201304
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: DUAC Drug Use Investigation
Trial description: This post-marketing surveillance (PMS) study is conducted to collect safety and effectiveness data in subjects with acne vulgaris who are treated with clindamycin phosphate hydrate and benzoyl peroxide for the first time. DUAC is a trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The incidence of adverse drug reactions

Timeframe: 12 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: clindamycin phosphate hydrate and benzoyl peroxide
    • Enrollment:
    2000
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Acne Vulgaris
    Product
    benzoyl peroxide, benzoyl peroxide/clindamycin phosphate, clindamycin phosphate
    Collaborators
    Not applicable
    Study date(s)
    June 2016 to April 2019
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Subjects with a diagnosis of acne vulgaris
    • Subjects who are treated with clindamycin phosphate hydrate and benzoyl peroxide for the first time
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with a diagnosis of acne vulgaris
    • Subjects who are treated with clindamycin phosphate hydrate and benzoyl peroxide for the first time
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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