Back to resultsEfficacy of Handheld Acne Heat Device
Primary Purpose
Acne Vulgaris
Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment
Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Are 12- 64 years old
- 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 any severe facial acne at baseline, including large acne lesions and cysts (nodulocystic acne)
- 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
Sites / Locations
- Skin Care Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Heat based treatment/no treatment
Heat based treatment/benzoyl peroxide
Arm Description
Split face treatment with handheld acne heat based device and no treatment
Split face treatment with handheld acne heat based device and benzoyl peroxide 4%
Outcomes
Primary Outcome Measures
Time to resolution of individual acne lesions
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.
Secondary Outcome Measures
Device tolerability
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
Split-face investigator's static global assessments will be conduced daily on subjects for 5 days.
Acne lesion counts
Lesion counts will be performed daily for 5 days.
Full Information
NCT ID
NCT01613924
First Posted
May 30, 2012
Last Updated
December 2, 2015
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01613924
Brief Title
Efficacy of Handheld Acne Heat Device
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 Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding and resources
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of our study is to determine the time to resolution of individual acne lesions using a popular handheld heat based device in comparison to no treatment and to standard topical therapy with benzoyl peroxide in order to determine its effectiveness in the spot treatment of acne vulgaris. Patient satisfaction and potential side effects will be examined as well.
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
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heat based treatment/no treatment
Arm Type
Placebo Comparator
Arm Description
Split face treatment with handheld acne heat based device and no treatment
Arm Title
Heat based treatment/benzoyl peroxide
Arm Type
Active Comparator
Arm Description
Split face treatment with handheld acne heat based device and benzoyl peroxide 4%
Intervention Type
Device
Intervention Name(s)
Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to resolution of individual acne lesions
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Device tolerability
Description
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.
Time Frame
5 days
Title
Split-face investigator's static global assessment
Description
Split-face investigator's static global assessments will be conduced daily on subjects for 5 days.
Time Frame
5 days
Title
Acne lesion counts
Description
Lesion counts will be performed daily for 5 days.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Are 12- 64 years old
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 any severe facial acne at baseline, including large acne lesions and cysts (nodulocystic acne)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Humphrey, MD, FRCPC
Organizational Affiliation
UBC Department of Dermatology and Skin Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skin Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z4E8
Country
Canada
12. IPD Sharing Statement
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Efficacy of Handheld Acne Heat Device
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