Using a topical antioxidant with laser treatments to reduce acne

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

This study is testing if using a special antioxidant serum along with laser treatments can help reduce oiliness and improve acne for people with mild to moderate cases.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Austin Institute for Clinical Research (network)
• Locations: 1 site (Pflugerville, Texas)
• Trial ID: NCT06376110 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a topical antioxidant serum combined with laser treatments to decrease sebum production in individuals with mild to moderate acne. It involves a split-face design where participants receive treatments on one side of their face while the other side serves as a control. Clinical efficacy will be measured through various assessments, including Investigator Global Assessment and sebum production metrics. Participants will also provide feedback on tolerability and product perception through questionnaires. Data will be collected and analyzed by an independent committee to ensure objectivity.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 65 with oily skin and mild to moderate acne.

Not a fit: Patients with severe acne or those with a history of facial skin cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for individuals struggling with acne.

How similar studies have performed: While similar approaches have been explored, this specific combination of topical antioxidants and laser treatments is relatively novel.

Eligibility criteria

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

Where this trial is running

Pflugerville, Texas

• Austin Institute for Clinical Research, Inc. — Pflugerville, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Edward Lain, MD, MBA — Austin Institute for Clinical Research
• Study coordinator: Alexsandra Scholler, BS

Conditions: Acne