Antioxidant Serum + Laser Treatment for Acne
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
23567How 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.
12378Eligibility 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
+4 more
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.
+9 more
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: Topical Antioxidant Serum containing Silymarin CF (Right Face)Active Control2 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 Control2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Austin Institute for Clinical Research, Inc.Pflugerville, TX
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Who Is Running the Clinical Trial?
Austin Institute for Clinical ResearchLead Sponsor
SkinCeuticalsCollaborator
References
Antioxidant Skincare Treatment for Hyperpigmented and Photodamaged Skin: Multi-Center, Open-Label, Cross-Seasonal Case Study. [2023]Label="Objective" NlmCategory="UNASSIGNED">The objective of this study is three-fold. Firstly, to evaluate an enhanced vitamin C serum (eVCS) and its' combination with a retinol-bakuchiol serum (RBS) on pigmentation in vitro. Secondly, to evaluate the effect of the eVCS on skin function ex vivo. Lastly, to evaluate eVCS and RSB in the treatment of facial hyperpigmentation and overall photodamage across a range of opposing environments.
Protective effects of a topical antioxidant complex containing vitamins C and E and ferulic acid against ultraviolet irradiation-induced photodamage in Chinese women. [2013]The objective of the study was to investigate whether a topical antioxidant complex containing vitamins C and E and ferulic acid can protect solar-simulated ultraviolet irradiation (ssUVR)-induced acute photodamage in human skin.
Ferulic acid stabilizes a solution of vitamins C and E and doubles its photoprotection of skin. [2013]Ferulic acid is a potent ubiquitous plant antioxidant. Its incorporation into a topical solution of 15%l-ascorbic acid and 1%alpha-tocopherol improved chemical stability of the vitamins (C+E) and doubled photoprotection to solar-simulated irradiation of skin from 4-fold to approximately 8-fold as measured by both erythema and sunburn cell formation. Inhibition of apoptosis was associated with reduced induction of caspase-3 and caspase-7. This antioxidant formulation efficiently reduced thymine dimer formation. This combination of pure natural low molecular weight antioxidants provides meaningful synergistic protection against oxidative stress in skin and should be useful for protection against photoaging and skin cancer.
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]The goal of this 12 week, double-blinded, controlled, clinical study was to compare the efficacy, tolerability, and consumer acceptance of three novel retinol serums to tretinoin.
Ferulic acid photoprotective properties in association with UV filters: multifunctional sunscreen with improved SPF and UVA-PF. [2018]Ultraviolet (UV) radiation stimulates several injurious biological effects on cutaneous tissue, causing, for instance, photocarcinogenesis. Sunscreens are topical products designed to protect the skin against these harmful effects and their use must be encouraged. The addition of antioxidants, as ferulic acid (FA), a phenolic compound from the class of the hydroxycinnamic acids, in sunscreens could improve their sun protection factor (SPF) and prevent inflammatory reactions. Here, the clinical safety and efficacy of an association of ethylhexyl triazone and bis-ethylhexyloxyphenol methoxyphenyl triazine (UV filters) with ferulic acid were assessed. Samples had good skin biocompatibility and presented satisfactory safety profile, even in a sun-exposed condition. A synergic effect between the natural polyphenol and the UV filters was evidenced, as well as, FA increased in vivo SPF in 37% and the UVA protection factor (UVA-PF) in 26%. The in vivo data indicated that FA reinforced the broad-spectrum characteristic of the photoprotective formulations. Additionally, according to the results from the ex vivo antioxidant test, it is plausible to recommend adjustments on the ex vivo protocol to explicitly determine the positive effects of topical antioxidant ingredients applied over the skin. These results provided a new perspective for the development of multifunctional bioactive sunscreens using FA as a new platform.
Safety profile of laser-assisted drug delivery of vitamin C, E, and ferulic acid serum following ablative fractional resurfacing: A retrospective chart review. [2022]Label="OBJECTIVES" NlmCategory="OBJECTIVE">The topical application of a combination Vitamin C, Vitamin E, and Ferulic acid serum following ablative fractional resurfacing has been reported to shorten post-procedure downtime and improve wound healing. However, transcutaneous drug delivery of cosmeceuticals initially meant for topical application have also been shown to have unintended side effects. The objective of our study was to report safety data from our single academic center experience consisting of patients treated with topical application of a vitamin C-containing cosmeceutical immediately following fractional ablative CO2 laser treatment with a focus on reportable side effects.
Ferulic Acid Activity in Topical Formulations: Technological and Scientific Prospecting. [2021]Ferulic acid is a phenolic compound widely distributed in monocotyledons, with several applications, especially in pharmaceutical and dermo-cosmetic industries. It has proven antioxidant and anti- inflammatory activities, among others, which are mainly ascribed to its molecular structure. The main factor that can lead to serious skin damages like inflammation, dryness, wrinkles, and cancer is the exposure to UV radiation that is responsible for an increased level of radical oxygen species.
Antioxidants in dermocosmetology: from the laboratory to clinical application. [2022]Oxygen situated in cutaneous cells can be activated by light. This makes the integumentary apparatus particularly vulnerable to oxidative damage and is responsible for the immediate cutaneous damage that is the basis of late phenomena, such as photo-induced ageing and tumours. Thus, the cosmetic industry has undertaken research and development into antioxidant-based products able to protect the skin from the effect of pro-oxidizing noxae. This review re-examines both antioxidants suitable for dermatological application and skin care products with antioxidant capacity, as well as the laboratory methods used to evaluate the effects and in vivo efficacy of antioxidants.