Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2013-07-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Heat based treatment/no treatment
Split face treatment with handheld acne heat based device and no treatment
Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment
Subjects will apply the actual device to every inflammatory acne facial lesion on one half of the face and no treatment to every inflammatory acne lesion on the other half of the face at 6 hour intervals for a total of 3 treatments. Follow up will occur daily over a 5 day period.
Heat based treatment/benzoyl peroxide
Split face treatment with handheld acne heat based device and benzoyl peroxide 4%
Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%
Subjects will apply the actual device to every inflammatory acne facial lesion on one half of the face at 6 hour intervals for a total of 3 treatments. Subjects will apply benzoyl peroxide to the other half of the face daily for 5 days.
Interventions
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Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment
Subjects will apply the actual device to every inflammatory acne facial lesion on one half of the face and no treatment to every inflammatory acne lesion on the other half of the face at 6 hour intervals for a total of 3 treatments. Follow up will occur daily over a 5 day period.
Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%
Subjects will apply the actual device to every inflammatory acne facial lesion on one half of the face at 6 hour intervals for a total of 3 treatments. Subjects will apply benzoyl peroxide to the other half of the face daily for 5 days.
Eligibility Criteria
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Inclusion Criteria
* Have an Investigator's Global Assessment of greater than or equal to 2
* Have 8-16 inflammatory acne facial lesions (papules and pustules)
Exclusion Criteria
* Have used any topical anti-acne medications, systemic antibiotics, and/or systemic corticosteroids 4 weeks before the study start
* Have used oral acne medications, such as Accutane (systemic retinoid), 6 months before the study start
* Have had a facial procedure 2 weeks before the study start
* Are nursing or pregnant
* Are using any oral contraceptives that have a specific anti-androgenic action or if you have started using a new oral contraceptive 12 weeks before the study start
* Are using any medications known to exacerbate acne
* Have a known hypersensitivity or allergy to benzoyl peroxide or any of the vehicle constituents
* Have a beard or facial hair that could interfere with study evaluations
12 Years
64 Years
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Principal Investigators
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Shannon Humphrey, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
UBC Department of Dermatology and Skin Science
Locations
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Skin Care Centre
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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H12-00792
Identifier Type: -
Identifier Source: org_study_id