Efficacy of Handheld Acne Heat Device

December 2, 2015 updated by: University of British Columbia

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4E8
        • Skin Care Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 64 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days
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.
5 days
Acne lesion counts
Time Frame: 5 days
Lesion counts will be performed daily for 5 days.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Shannon Humphrey, MD, FRCPC, UBC Department of Dermatology and Skin Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (ESTIMATE)

June 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H12-00792

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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