Efficacy of Handheld Acne Heat Device
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|ClinicalTrials.gov Identifier: NCT01613924|
Recruitment Status : Withdrawn (Lack of funding and resources)
First Posted : June 7, 2012
Last Update Posted : December 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Device: Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment Device: Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of a Handheld Heat Based Device for the Spot Treatment of Mild to Moderate Acne Vulgaris: A Controlled Study to Determine Time to Resolution of Individual Inflammatory Lesions Using an Over-the-counter Acne Heat Device.|
|Study Start Date :||July 2013|
|Primary Completion Date :||June 2014|
|Study Completion Date :||June 2014|
Placebo Comparator: Heat based treatment/no treatment
Split face treatment with handheld acne heat based device and no treatment
Device: 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.
Active Comparator: Heat based treatment/benzoyl peroxide
Split face treatment with handheld acne heat based device and benzoyl peroxide 4%
Device: 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.
- Time to resolution of individual acne lesions [ Time Frame: 5 days ]Subjects will be photographed daily and the progression of individual acne lesions will be followed. Time to resolution of each lesion will be determined for the various treatment groups.
- Device tolerability [ Time Frame: 5 days ]Device tolerability will be assessed daily by asking the subject about adverse effects experienced from the treatments. At the end of 5 days, subjects will be asked to rate the various treatments based on ease of use and how much the side effects bothered him or her.
- Split-face investigator's static global assessment [ Time Frame: 5 days ]Split-face investigator's static global assessments will be conduced daily on subjects for 5 days.
- Acne lesion counts [ Time Frame: 5 days ]Lesion counts will be performed daily for 5 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613924
|Canada, British Columbia|
|Skin Care Centre|
|Vancouver, British Columbia, Canada, V5Z4E8|
|Principal Investigator:||Shannon Humphrey, MD, FRCPC||UBC Department of Dermatology and Skin Science|