Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris

Sebacia

Status: Completed

Conditions: Acne Vulgaris

Treatments: Device: Sebacia Microparticles; Device: Nd:Yag Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT03303170

SEB-0493

Details and patient eligibility

About

Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris

Enrollment: 168 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild to moderate acne vulgaris
• At least 15 inflammatory acne lesions
• Skin phototype I - III
• Able to understand and comply with study requirements

Exclusion criteria

• Severe acne vulgaris
• Nodulocystic acne
• Ongoing use of medications and/or treatments for acne
• New hormone regimen (used for less than 12 weeks)
• Significant medical or mental health condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

Sebacia Microparticles

Experimental group

Treatment:

Device: Sebacia Microparticles

Nd:Yag Laser

Active Comparator group

Treatment:

Device: Nd:Yag Laser