Recruiting

Topical Antioxidant

Sponsor:

Austin Institute for Clinical Research

Code:

NCT06376110

Conditions

Acne

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Topical Antioxidant Serum

AviClear Laser

Study Details

Brief 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.

Conditions

Acne

Study ID

NCT06376110

Start date

Apr 24, 2024

Status verified date

May, 2024

Completion date

Apr 24, 2025

Anticipated

Primary completion date

Apr 24, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Topical Antioxidant Serum containing Silymarin CF (Left Face)

14 day application of topical antioxidant serum containing Silymarin CF

Subjects will be given study drug and instructed to topically apply to the treatment area, the respectively randomized half of the face, once daily for 14 consecutive days.

active comparator: Topical Antioxidant Serum containing Silymarin CF (Right Face)

14 day application of topical antioxidant serum containing Silymarin CF

Subjects will be given study drug and instructed to topically apply to the treatment area, the respectively randomized half of the face, once daily for 14 consecutive days.

Interventions

Topical 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.

AviClear 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.

Primary outcome measure

  • Change in Facial Acne Severity [ Time Frame: Change from Baseline at Day 98 ]
  • Change in Subject Tolerability [ Time Frame: Change from Baseline at Day 98 ]

Central Contacts and Locations

Central contacts

Locations

Austin Institute for Clinical Research, Inc.

Recruiting

Pflugerville, Texas, United States, 78660

Contacts

Principal Investigator:

Edward L Lain, MD

More Information

Sponsor

Austin Institute for Clinical Research

Last update posted

May 16, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Austin Institute for Clinical Research on 2024-05-16.