Efficacy of Handheld Acne Heat Device

Acne Vulgaris Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01613924
• Other study ID #: H12-00792
• Status: Withdrawn
• Phase: Phase 4
• First received: May 30, 2012
• Last updated: December 2, 2015
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. Patient satisfaction and potential side effects will be examined as well.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 64 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Skin Care Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 days	No
Secondary	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.	5 days	Yes
Secondary	Split-face investigator's static global assessment	Split-face investigator's static global assessments will be conduced daily on subjects for 5 days.	5 days	No
Secondary	Acne lesion counts	Lesion counts will be performed daily for 5 days.	5 days	No