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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an antioxidant serum used with laser treatments can reduce oily skin in people with mild to moderate acne. Researchers apply the serum to one side of the face to observe its effect on oil production. Ideal participants are healthy adults who perceive their skin as oily and have mild to moderate acne. This trial suits those not currently using strong acne medications or undergoing other facial treatments. As an unphased trial, it offers participants a unique chance to contribute to early-stage research and potentially benefit from innovative skincare solutions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the topical antioxidant serum, containing silymarin, vitamin C, and ferulic acid, is generally safe for skin use. Studies have found that these ingredients help maintain skin hydration, reduce dark spots, and protect against pollution. They also lower oxidative stress, which can damage skin cells.

Ferulic acid is especially well-tolerated by most people, helping to stabilize vitamin C and enhance its effectiveness for the skin. However, like any skincare product, some individuals might experience mild irritation.

One study found that a serum with silymarin and these antioxidants reduced acne and improved skin texture, suggesting the serum is both effective and safe for treating facial issues.

Overall, the ingredients in this antioxidant serum are well-tolerated, with few reports of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this antioxidant serum for acne because it utilizes Silymarin CF, an ingredient not commonly found in standard treatments. Most acne treatments, like benzoyl peroxide or salicylic acid, focus on reducing bacteria or exfoliating the skin. In contrast, Silymarin CF offers potent antioxidant properties that can help soothe inflammation and protect skin cells from oxidative stress. This unique mechanism of action could provide a gentler option for acne sufferers, potentially reducing redness and irritation more effectively than traditional treatments.

What evidence suggests that this trial's treatments could be effective for acne?

Research shows that a skin serum containing silymarin, vitamin C, ferulic acid, and salicylic acid can help reduce facial acne. One study found that this serum improved acne and enhanced overall skin appearance. The antioxidants in the serum, such as vitamin C and ferulic acid, help maintain skin health by reducing swelling and protecting against damage. Another study found that the serum also improved skin tone and reduced redness. In this trial, participants will apply the antioxidant serum containing Silymarin CF to one half of their face. These findings suggest that this antioxidant serum could be a promising treatment for acne. ^{1 5 6 7 8}

Who Is on the Research Team?

Edward L Lain, MD

Principal Investigator

Austin Institute for Clinical Research

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12175833/

Ferulic Acid Use for Skin Applications: A Systematic Review Daily use of topical 0.5 to 1% FA for at least 1 to 3 months appears to achieve therapeutic benefits, such as improved skin erythema, hyperpigmentation, ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jdv.20070

Efficacy and safety of a topical skincare regimen containing ... Considering the evidence presented, combined use of CE Ferulic serum in the morning and RBE serum at night may be a beneficial skincare regimen ...

3. jaad.org jaad.org/article/S0190-9622(15)00201-7/fulltext

Long-term evaluation of postoperative vitamin C, E and ... Trend analysis showed an evener skin tone at T30 and T60 for antioxidant side, achieving a 18% overall improvement, when comparing to placebo (10% improvement).

4. jddonline.com jddonline.com/articles/a-silymarin-antioxidant-serum-improves-facial-acne-alone-and-as-part-of-a-treatment-regimen-S1545961624P0233X/?_page=5

A Silymarin Antioxidant Serum Improves Facial Acne Alone ... A topical serum containing 0.5% silymarin, 15% vitamin C, 0.5% ferulic acid, and 0.5% salicylic acid was effective in reducing facial acne and improving ...

5. lorealdermatologicalbeauty.com lorealdermatologicalbeauty.com/-/media/project/loreal/brand-sites/acdpro/master/dmi/skinceuticals/download-pages/kim-jcd-2020.pdf?rev=7a8134ffe6bf4f3bbfc5782d536c8e69

Effect of a topical antioxidant serum containing vitamin C, ... Conclusions: Our study suggests that topical application of a combination vitamins. C, E, and ferulic acid antioxidant formula may be effective ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6549792/

Skin protective effects of an antipollution, antioxidant serum ... The serum improved skin hydration, reduced dark spots, and improved the skin barrier function and reduced oxidative stress.

7. jcadonline.com jcadonline.com/ferulic-acid-use-for-skin-applications/

Ferulic Acid Use for Skin Applications: A Systematic Review Daily use of topical 0.5 to 1% FA for at least 1 to 3 months appears to achieve therapeutic benefits, such as improved skin erythema, hyperpigmentation, ...

8. seoulceuticals.com seoulceuticals.com/blogs/news/skincare-real-talk-who-should-not-use-ferulic-acid?srsltid=AfmBOopCZ0vTIeiBq20o24gVv953gcuhgy6-841TYDcbTPPEA6MMLmYf

Skincare Real Talk: Who Should NOT Use Ferulic Acid? Ferulic acid is generally well-tolerated. It offers impressive support for vitamin C, helping it stay stable and active. Yet even the gentlest ingredient can ...