Single-Blind Study Assessing the Use of a Topical Antioxidant With A Series of Laser Procedures to Reduce Sebum Production

Launched by AUSTIN INSTITUTE FOR CLINICAL RESEARCH · Apr 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special antioxidant serum combined with laser treatments to help reduce oily skin and acne. It involves healthy men and women between the ages of 18 and 65 who have self-reported oily skin and mild to moderate acne. Participants will have treatments on one side of their face while the other side serves as a comparison. This study is currently recruiting participants who meet specific criteria, such as not having certain medical conditions or recent skin treatments.

If you’re considering joining, you’ll need to be generally healthy, not pregnant or nursing, and willing to follow the study's guidelines. Participants will need to sign consent forms and may have their photographs taken to track progress. Overall, this trial aims to find out if the antioxidant serum can effectively work with laser treatments to improve acne and reduce oiliness in the skin.

Gender

ALL

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