Efficacy of Handheld Acne Heat Device

This study has suspended participant recruitment.
(Insufficient resources)
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01613924
First received: May 30, 2012
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Time to resolution of individual acne lesions [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Split-face investigator's static global assessments will be conduced daily on subjects for 5 days.

  • Acne lesion counts [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Lesion counts will be performed daily for 5 days.


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613924

Locations
Canada, British Columbia
Skin Care Centre
Vancouver, British Columbia, Canada, V5Z4E8
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Shannon Humphrey, MD, FRCPC UBC Department of Dermatology and Skin Science
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01613924     History of Changes
Other Study ID Numbers: H12-00792
Study First Received: May 30, 2012
Last Updated: June 3, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014