Acne VulgarisPhase 4NCT01613924
Efficacy of Handheld Acne Heat Device
A Phase 4 study testing Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment and Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4% in people with Acne Vulgaris, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment and Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Acne Vulgaris
- Being tested
- 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%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split face: handheld acne heat based device (Zeno Hot Spot) and no treatmentDevice
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%Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Heat based treatment/no treatment | Placebo comparator | Split face treatment with handheld acne heat based device and no treatment Receives: Device: Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment |
| Heat based treatment/benzoyl peroxide | Active comparator | Split face treatment with handheld acne heat based device and benzoyl peroxide 4% Receives: Device: Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (3)
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.
Measured: 5 days
Split-face investigator's static global assessment
Split-face investigator's static global assessments will be conduced daily on subjects for 5 days.
Measured: 5 days
Acne lesion counts
Lesion counts will be performed daily for 5 days.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Lack of funding and resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon Humphrey, MD, FRCPC, Principal investigator, UBC Department of Dermatology and Skin Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613924
- Sponsor's protocol ID
- H12-00792
- Status last verified
- Dec 2015
- First submitted
- 30 May 2012
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01613924
- Acronym / sponsor ID
- H12-00792
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding and resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat based treatment/no treatment | Placebo comparator | Device: Split face: handheld acne heat based device (Zeno Hot Spot) and no treatmentSplit face treatment with handheld acne heat based device and no treatment |
| Heat based treatment/benzoyl peroxide | Active comparator | Device: Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%Split face treatment with handheld acne heat based device and benzoyl peroxide 4% |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Split face: handheld acne heat based device (Zeno Hot Spot) and no treatmentSubjects 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. | Device | Heat based treatment/no treatment |
| 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. | Device | Heat based treatment/benzoyl peroxide |
Primary outcome
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.
3 secondary outcomes
Device tolerability
Time frame: 5 days
Split-face investigator's static global assessment
Time frame: 5 days
Acne lesion counts
Time frame: 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Humphrey, MD, FRCPC principal investigator
UBC Department of Dermatology and Skin Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment and Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4% in people with Acne Vulgaris, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of individual acne lesions (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.