Efficacy of Handheld Acne Heat Device

University of British Columbia

Status and phase

Withdrawn

Phase 4

Conditions

Acne Vulgaris

Treatments

Device: Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%

Device: Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01613924

H12-00792

Details and patient eligibility

About

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.

Sex

All

Ages

12 to 64 years old

Volunteers

Accepts Healthy Volunteers

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