Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Sebacia

Status: Completed

Conditions: Acne Vulgaris

Treatments: Device: Sebacia microparticle and laser treatment; Device: Vehicle and laser treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02219074

SEB-0005

Details and patient eligibility

About

Prospective, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of acne vulgaris.

Enrollment: 350 patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of moderate to severe acne vulgaris

Exclusion criteria

• use of oral retinoid therapy in the past 12 months
• pregnancy, lactating, or planning to become pregnant
• excessive scarring in the treatment area, or other condition that would impact the ability to evaluate acne

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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350 participants in 2 patient groups

Sebacia microparticle and laser treatment

Experimental group

Treatment:

Device: Sebacia microparticle and laser treatment

Vehicle and laser treatment

Sham Comparator group

Treatment:

Device: Vehicle and laser treatment