Sebacia Postmarket Study of Real-World Use

Sebacia, Inc.125 enrolled

Overview

Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

125

Conditions

Acne Vulgaris

Interventions

Sebacia Microparticles TreatmentOTHER

Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3) * Between 10 and 50 papules/pustules * Fitzpatrick skin phototype I, II or III * Able to provide informed consent and comply with study schedule and other requirements Exclusion Criteria: * Moderately severe or severe acne vulgaris (IGA 4 or 5) * Nodulocystic acne, significant scarring or excoriation * Requires oral retinoid, antibiotic or corticosteroid for acne * New or fluctuating hormone or hormone-regulating therapy * Photosensitivity or allergy to gold * Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation

Locations (6)

Miami Dermatology & Laser Institute

Miami, Florida, United States

Dermatology Institute of Boston

Boston, Massachusetts, United States

International Clinical Research

Murfreesboro, Tennessee, United States

Austin Institute for Clinical Research - Central

Austin, Texas, United States

Outcomes

Primary Outcomes

Inflammatory Lesion Count

Percent change in number of inflammatory lesions from baseline

Time frame: Months 2, 3, 6, 9 and 12

Secondary Outcomes

Investigator's Global Assessment

Percent of subjects clear (IGA 0) or almost clear (IGA 1)

Time frame: Months 2, 3, 6, 9 and 12

Physician's Overall Assessment of Improvement

Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete)

Time frame: Months 2, 3, 6, 9 and 12

Data from ClinicalTrials.gov

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