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

AviClear-001

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.

2024-04-24

2025-04-24

2025-04-24

Recruiting

10

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 throughout participation in study (See Section 6.1.1) 6. Willingness to cooperate and participate by following study requirements 7. Individuals must sign an informed consent and a photography consent Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Subjects that are being treated for cancer or have a history of facial skin cancer on the test areas 2. Subjects with sunburn, moderate to pronounced suntan, pronounced asymmetric skin aging, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results 3. Subjects currently taking certain medications which in the opinion of the Investigators may interfere with the study. This includes but not limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids \[steroid nose drops, inhalers and/or eye drops are permitted\]), and immunosuppressive drugs 4. Subjects with self-reported, uncontrolled systemic disease which, in the opinion of the Investigator, may hinder either the subject 's ability to perform all responsibilities of the trial or the Investigator's ability to perform assessments 5. Females known to be pregnant, nursing or planning to become pregnant 6. Subjects participating in other facial clinical studies 7. Subjects who have routinely used an alpha-hydroxy-acid (AHA) or a beta-hydroxy-acid (BHA) containing product within two weeks or Retin-A, Retin-A Micro, Renova ,Differin , Avita, Tazorac, or Soriatane within 8 weeks of the study start or have taken Accutane within one year of the study start. Subjects who have used Retinol in the last 8 weeks 8. Subjects with history of severe acne flares 9. Subjects who have had ablative laser treatments, microneedling, and/or chemical peels or dermabrasion within the last six months 10. Subjects who have had non-ablative laser treatments or IPL within the last 3 months 11. Subjects with known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs 12. Subjects currently using topically applied prescription medications on the face

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

2024-05-16