Antioxidant Serum + Laser Treatment for Acne

Overseen By Celeste Katona, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Austin Institute for Clinical Research

Must not be taking: Anti-inflammatories, Immunosuppressives, Retinoids, others

Disqualifiers: Cancer, Uncontrolled systemic disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 98

Duration: 10 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You might need to stop certain medications if they could interfere with the study. This includes high doses of anti-inflammatory drugs and immunosuppressive drugs. Also, if you're using certain skin treatments or prescription medications on your face, you may need to stop those before joining the trial.

What data supports the effectiveness of the Antioxidant Serum + Laser Treatment for Acne?

Research shows that antioxidant serums containing vitamins C and E, along with ferulic acid, can protect skin from sun damage and improve skin health. These ingredients help stabilize each other and enhance skin protection, which may also benefit acne treatment by reducing inflammation and promoting skin repair. ^{1 2 3 4 5}

Is the combination of antioxidant serum and laser treatment safe for human use?

Research shows that the combination of Vitamin C, E, and Ferulic acid serum, when used with laser treatments, generally has a good safety profile and can improve skin healing. However, there may be some unintended side effects when these serums are used in ways not originally intended, such as through laser-assisted delivery. ^{2 3 5 6 7}

How is the Antioxidant Serum + Laser Treatment for Acne different from other acne treatments?

This treatment is unique because it combines a topical antioxidant serum containing vitamins C and E with ferulic acid, which enhances the stability and effectiveness of the vitamins, providing increased protection against skin damage from sunlight. This approach not only targets acne but also offers additional benefits like reducing skin aging and damage from UV exposure, which is not typically addressed by standard acne treatments. ^{1 2 3 7 8}

What is the purpose of this trial?

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.

Research Team

Edward L Lain, MD

Principal Investigator

Austin Institute for Clinical Research

Eligibility Criteria

This trial is for healthy men and women aged 18-65 with mild to moderate acne who perceive their skin as oily. Participants must use approved birth control, have no health issues affecting the study, and agree to follow the study's rules including signing consent forms.

Inclusion Criteria

My acne is mild to moderate.

I am between 18 and 65 years old and have a skin type ranging from very fair to very dark.

No known medical conditions that, in the Investigator's opinion may interfere with study participation

Exclusion Criteria

My skin is clear of sunburn, tattoos, scars, or other marks that could affect test results.

Subjects participating in other facial clinical studies

I have not had non-ablative laser or IPL treatments in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a topical antioxidant serum and undergo laser treatments to reduce sebum production

10 weeks

Visits on Day 0, 14, 42, and 70

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Final follow-up visit on Day 98

Treatment Details

Interventions

• Topical Antioxidant Serum

Trial Overview The study tests if a topical antioxidant serum can boost the effectiveness of AviClear laser treatments in reducing sebum production on one side of the face compared to laser treatment alone on the other side.

Participant Groups

Group I: Topical Antioxidant Serum containing Silymarin CF (Right Face) Active Control 2 Interventions

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.

Group II: Topical Antioxidant Serum containing Silymarin CF (Left Face) Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Austin Institute for Clinical Research

Lead Sponsor

Trials

6

Recruited

140+

SkinCeuticals

Collaborator

Trials

4

Recruited

110+

Findings from Research

The enhanced vitamin C serum (eVCS) significantly increased collagen levels in treated skin explants by 145% compared to control, indicating its potential to improve skin structure.

The combination of eVCS with a retinol-bakuchiol serum (RSB) was more effective in reducing pigmentation than eVCS alone, showing significant clinical improvement in facial hyperpigmentation and photodamage over a 12-week study with 29 female participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antioxidant Skincare Treatment for Hyperpigmented and Photodamaged Skin: Multi-Center, Open-Label, Cross-Seasonal Case Study. Hooper, D., Tedaldi, R., Iglesia, S., et al.[2023]

In a study involving 12 healthy female participants, a topical antioxidant complex with vitamins C and E and ferulic acid significantly protected against skin damage caused by solar-simulated ultraviolet irradiation (ssUVR).

The antioxidant complex reduced harmful effects such as sunburn cell formation and thymine dimer formation, indicating its potential as an effective photoprotective treatment for acute skin damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective effects of a topical antioxidant complex containing vitamins C and E and ferulic acid against ultraviolet irradiation-induced photodamage in Chinese women. Wu, Y., Zheng, X., Xu, XG., et al.[2013]

Incorporating ferulic acid into a topical solution with 15% l-ascorbic acid and 1% alpha-tocopherol significantly enhances the stability of these vitamins and doubles the skin's protection against UV damage, increasing photoprotection from 4-fold to approximately 8-fold.

The antioxidant formulation not only reduces skin cell damage by inhibiting apoptosis (cell death) through lower levels of caspase-3 and caspase-7 but also effectively decreases thymine dimer formation, suggesting it could be beneficial in preventing photoaging and skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferulic acid stabilizes a solution of vitamins C and E and doubles its photoprotection of skin. Lin, FH., Lin, JY., Gupta, RD., et al.[2013]

In a 12-week study involving 45 women aged 35-65 with moderate wrinkling, retinol serums showed comparable or better efficacy and tolerability compared to tretinoin creams, particularly in improving skin smoothness and reducing dryness.

Histological analysis revealed that retinol serum users experienced greater collagen formation and epidermal thickening than those using tretinoin, indicating a potentially more beneficial effect on skin structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Double-Blind, Comparative Clinical Study of Newly Formulated Retinol Serums vs Tretinoin Cream in Escalating Doses: A Method for Rapid Retinization With Minimized Irritation. Draelos, ZD., Peterson, RS.[2021]

The combination of ferulic acid (FA) with UV filters in sunscreens significantly enhances their effectiveness, increasing the sun protection factor (SPF) by 37% and UVA protection factor (UVA-PF) by 26%, demonstrating improved skin protection against UV radiation.

The formulation showed good skin compatibility and a satisfactory safety profile, even when exposed to sunlight, suggesting that incorporating antioxidants like FA into sunscreens can provide additional protective benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferulic acid photoprotective properties in association with UV filters: multifunctional sunscreen with improved SPF and UVA-PF. Peres, DD., Sarruf, FD., de Oliveira, CA., et al.[2018]

In a study of 33 patients who received fractional ablative CO2 laser treatment followed by a Vitamin C, E, and Ferulic acid serum, there were no reported complications from the serum application, indicating it is safe for immediate post-procedure use.

While expected side effects like erythema and skin peeling occurred, they were attributed to the laser treatment itself and resolved without complications, suggesting that the serum does not exacerbate post-procedure effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of laser-assisted drug delivery of vitamin C, E, and ferulic acid serum following ablative fractional resurfacing: A retrospective chart review. Johnson, H., Kazemi, T., Farah, RS.[2022]

Ferulic acid is a potent antioxidant and anti-inflammatory compound that can help protect the skin from UV radiation damage, which is linked to issues like inflammation and wrinkles.

The review highlights that combining ferulic acid with other vitamins and using advanced technologies can enhance its stability and bioavailability in topical formulations, making it a promising option for treating various skin disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferulic Acid Activity in Topical Formulations: Technological and Scientific Prospecting. Cavalcanti, GR., Duarte, FIC., Converti, A., et al.[2021]

Skin cells can be damaged by light-activated oxygen, leading to immediate harm and long-term issues like aging and skin cancer.

The cosmetic industry is focusing on developing antioxidant products to protect the skin from oxidative damage, and this review highlights various antioxidants suitable for skin care and the methods used to test their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antioxidants in dermocosmetology: from the laboratory to clinical application. Andreassi, M., Andreassi, L.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Antioxidant Skincare Treatment for Hyperpigmented and Photodamaged Skin: Multi-Center, Open-Label, Cross-Seasonal Case Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Protective effects of a topical antioxidant complex containing vitamins C and E and ferulic acid against ultraviolet irradiation-induced photodamage in Chinese women. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Ferulic acid stabilizes a solution of vitamins C and E and doubles its photoprotection of skin. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

A Double-Blind, Comparative Clinical Study of Newly Formulated Retinol Serums vs Tretinoin Cream in Escalating Doses: A Method for Rapid Retinization With Minimized Irritation. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Ferulic acid photoprotective properties in association with UV filters: multifunctional sunscreen with improved SPF and UVA-PF. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Safety profile of laser-assisted drug delivery of vitamin C, E, and ferulic acid serum following ablative fractional resurfacing: A retrospective chart review. [2022]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Ferulic Acid Activity in Topical Formulations: Technological and Scientific Prospecting. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Antioxidants in dermocosmetology: from the laboratory to clinical application. [2022]