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

NCT06376110 | Recruiting DMC FDA Device

• 1 other identifier: AviClear-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in Facial Acne Severity

  Measured by Live Clinical Investigator grading of overall severity of facial acne using the Investigator Global Assessment (IGA). The parameters of the scale are as follows, 0 = clear (best possible outcome), 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe (worst possible outcome). A decrease in scores indicates an improvement in study treatment efficacy. The null hypothesis is that the mean change from baseline is zero.

  Change from Baseline at Day 98

• Change in Subject Tolerability

  Measured by Live Clinical Investigator grading by subject reporting of burning, stinging, and itching. Each will be measured with the following parameters, 0 = none (best possible outcome), 1 = mild, 2 = moderate, and 3 = severe (worst possible outcome). A decrease in scores or lack of significant increases indicate tolerability of the study treatment. The null hypothesis is that the mean change from baseline is zero.

  Change from Baseline at Day 98

Secondary Outcomes (1)

• Change in Skin Quality

  Change from Baseline at Day 98

Study Arms (2)

Topical Antioxidant Serum containing Silymarin CF (Left Face)

ACTIVE COMPARATOR

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.

Drug: Topical Antioxidant Serum; Device: AviClear Laser

Topical Antioxidant Serum containing Silymarin CF (Right Face)

ACTIVE COMPARATOR

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.

Drug: Topical Antioxidant Serum; Device: AviClear Laser

Interventions

Topical Antioxidant Serum DRUG

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.

Also known as: SkinCeuticals Silymarin CF

Topical Antioxidant Serum containing Silymarin CF (Left Face); Topical Antioxidant Serum containing Silymarin CF (Right Face)

AviClear Laser DEVICE

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.

Topical Antioxidant Serum containing Silymarin CF (Left Face); Topical Antioxidant Serum containing Silymarin CF (Right Face)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female subjects aged between 18 and 65 years, inclusive of all Fitzpatrick Skin Types (I-VI)
• Self-perceived "oily skin". Subject must answer "Yes" to the question "Do you have an oily complexion?"
• Mild to moderate acne (2-3) based on IGA
• No known medical conditions that, in the Investigator's opinion may interfere with study participation
• 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)
• Willingness to cooperate and participate by following study requirements
• Individuals must sign an informed consent and a photography consent

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• Subjects that are being treated for cancer or have a history of facial skin cancer on the test areas
• 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
• 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
• 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
• Females known to be pregnant, nursing or planning to become pregnant
• Subjects participating in other facial clinical studies
• 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
• Subjects with history of severe acne flares
• Subjects who have had ablative laser treatments, microneedling, and/or chemical peels or dermabrasion within the last six months
• Subjects who have had non-ablative laser treatments or IPL within the last 3 months
• Subjects with known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs
• Subjects currently using topically applied prescription medications on the face

Sponsors & Collaborators

• Austin Institute for Clinical Research: lead
• SkinCeuticals: collaborator

Study Sites (1)

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Edward Lain, MD, MBA

  Austin Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexsandra Scholler, BS

CONTACT

5122792545; iitcoordinator@atxresearch.com

Celeste Katona, BA

CONTACT

5122792545; ckatona@atxresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: April 24, 2024
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)