Efficacy of Handheld Acne Heat Device

Phase 4

Withdrawn

• Conditions: Acne Vulgaris

• Registration Number: NCT01613924
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-07
• Study Start: 2013-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to resolution of individual acne lesions	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.

Secondary Outcome Measures

Name	Time	Method
Split-face investigator's static global assessment	5 days	Split-face investigator's static global assessments will be conduced daily on subjects for 5 days.
Device tolerability	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.
Acne lesion counts	5 days	Lesion counts will be performed daily for 5 days.

Trial Locations

Locations (1)

Skin Care Centre; 🇨🇦 Vancouver, British Columbia, Canada