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
Observational study model:
Case-Only
Primary completion date:
Not applicable
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)

No location data available.

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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