Acne Vulgaris
Conditions
Brief summary
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.
Interventions
OTHERSebacia Microparticles Treatment
Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.
Sponsors
Sebacia, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Lesion Count | Months 2, 3, 6, 9 and 12 | Percent change in number of inflammatory lesions from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment | Months 2, 3, 6, 9 and 12 | Percent of subjects clear (IGA 0) or almost clear (IGA 1) |
| Physician's Overall Assessment of Improvement | Months 2, 3, 6, 9 and 12 | Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete) |
Countries
United States
Outcome results
None listed