A Split-Face, Single-Blind, Study Assessing the Use of a Topical Antioxidant Containing Silymarin With A Series of 1726nm Laser Procedures to Reduce Sebum Production
Austin Institute for Clinical Research
Summary
This is a split-face, single-blind study assessing the use of an antioxidant serum with a series of acne laser treatments to reduce sebum production in healthy male and female subjects between the ages of 18 and 65 years, inclusive, with Fitzpatrick skin types I-VI.
Description
A single-center study. Clinical efficacy will be assessed using Investigator Global Assessment (IGA). Instrumentation will be assessed using VISIA imaging procedures, and sebumeter (sebum production). Tolerability will be assessed in subjects through objective tolerance grading and subjective tolerance assessment. In addition, subject perception of product will be evaluated by questionnaires. Live investigator clinical efficacy grading, tolerance evaluations, and subject self-assessments; will be performed at baseline (Day 0), Day 14, Day 42, and Day 70. Additionally instrumentation measuremen…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Subjects must meet all the inclusion criteria in order to be eligible for this study: 1. Healthy male and female subjects aged between 18 and 65 years, inclusive of all Fitzpatrick Skin Types (I-VI) 2. Self-perceived "oily skin". Subject must answer "Yes" to the question "Do you have an oily complexion?" 3. Mild to moderate acne (2-3) based on IGA 4. No known medical conditions that, in the Investigator's opinion may interfere with study participation 5. Female subjects of childbearing potential must be on and remain on a study-specified stable form of birth control throu…
Interventions
- DrugTopical Antioxidant Serum
An oil-free vitamin C serum for oily skin and blemish-prone skin that delivers advanced environmental protection, reduces oiliness, refines skin texture, and visibly improves skin clarity and fine lines.
- DeviceAviClear Laser
The AviClear (1726nm) laser is FDA-cleared for use on mild to severe inflammatory acne, with a recommended treatment course comprised of 3 laser procedures each one month apart.
Location
- Austin Institute for Clinical Research, Inc.Pflugerville, Texas