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

A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial Inflammatory Acne Vulgaris

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03303170

Enrollment

168

Registered

2017-10-05

Start date

2017-09-25

Completion date

2018-04-10

Last updated

2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Brief summary

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

Interventions

DEVICESebacia Microparticles

Topical microparticle suspension

DEVICENd:Yag Laser

Laser delivering 1064 nm wavelength light

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Change in number of inflammatory acne lesions	Week 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026