Enhanced efficacy of a topical antioxidants regimen in conjunction with a home-use non-ablative fractional diode laser in photodamaged facial skin.

BACKGROUND: Photodamaged facial skin is characterized by fine lines and wrinkles, mottled pigmentation, and other changes. OBJECTIVE: To evaluate and compare the efficacy and tolerance of a home-use laser device when used alone or in combination with an antioxidant facial treatment for moderate photodamage. METHODS: This was a 49-subject, evaluator-blinded, split-face, randomized, single-center, 24-week, phase-2, study. In phase 1, all subjects were treated on one facial side with test products and a home-use laser device and the other side was treated with laser alone for 12 weeks, followed by a 2-week regression period during which they used only support materials. For phase 2, all subjects were divided into 2 independent treatment groups. For the next 10 weeks, subjects of first group treated the assigned facial side with test products and support materials and the other facial side with only support materials. Subjects in the second group treated their entire face with only support materials. Efficacy and tolerance were assessed by clinical grading, VISIA-CR imaging, and self-assessment questionnaires. RESULTS: The combination of laser and test products improved all photodamage parameters evaluated. CONCLUSION: The test products enhanced and prolonged clinical benefits obtained with the laser alone.

A method for maintaining the clinical results of 4% hydroquinone and 0.025% tretinoin with a cosmeceutical formulation.

Facial dyspigmentation treatment is an unmet need in dermatology with increasing challenges due to the questionable safety of hydroquinone. This research examined a new OTC formulation containing hydroxyphenoxy propionic acid, ellagic acid, yeast extract, and salicylic acid on subjects who previously completed 12 weeks of treatment with 4% hydroquinone and 0.025% retinoic acid. The goal of this study was to evaluate the skin lightening and tolerability profile of a 20-week maintanence therapy with a cosmeceutical formulation during the summer months. 33 healthy subjects ages 25-60 years with moderate facial dyspigmentation defined as a score of 3 on a 5-point scale were enrolled. There was statistically significant improvement at week 20 in terms of even skin tone (P<0.001), spot intensity (P<0.001), spot size (P<0.05) and overall hyperpigmentation (P>=0.002).

Evaluation of efficacy and tolerance of a nighttime topical antioxidant containing resveratrol, baicalin, and vitamin e for treatment of mild to moderately photodamaged skin.

Resveratrol is an effective anti-aging molecule with diverse biologic activity. It functions as a dual antioxidant that can neutralize free radicals and increase intrinsic antioxidant capacity. Additionally resveratrol increases mitochondrial biogenesis and has anti-inflammatory, anti-diabetic, and anti-cancer activity. In this paper we will focus on the use of topically applied resveratrol using a proprietary blend containing 1% resveratrol, 0.5% baicalin, and 1% vitamin E. This stabilized high concentration formulation demonstrates percutaneous absorption and alterations in gene expression such as hemoxygenase-1 (HO-1), vascular endothelial growth factor (VEGFA), and collagen 3 (COL3A1). Clinical assessment showed a statistically significant improvement in fine lines and wrinkles, skin firmness, skin elasticity, skin laxity, hyperpigmentation, radiance, and skin roughness over baseline in 12 weeks. Ultrasound measurements in the periorbital area showed an average improvement of 18.9% in dermal thickness suggesting significant dermal remodeling. These studies confirm that topical resveratrol, baicalin, and vitamin E are valuable ingredient that can be used for skin rejuvenation.

Complementary clinical effects of topical tightening treatment in conjunction with a radiofrequency procedure.

UNLABELLED: Abstract Background: Skin laxity and cellulite on the buttocks and thighs are two common cosmetic concerns. Skin tightening with radiofrequency (RF) devices has become increasingly popular. OBJECTIVE: The purpose of this study is to evaluate the efficacy and safety of a topical skin laxity tightening agent when used in combination with an RF device. METHODS: A double-blinded, randomized clinical trial enrolled twenty females with mild-to-moderate skin laxity on the posterior thighs/buttocks. Each subject underwent two monthly treatments with an RF source (Alma Accent) to both legs. Subjects were then randomized to apply a topical agent (Skinceuticals Body Tightening Concentrate) twice daily to only one designated thigh/buttock throughout the eight-week duration of the study. All subjects were evaluated for improvement in lifting, skin tone, radiance, firmness/tightness, skin texture, and overall appearance based on photographic evaluation by blinded investigators at 12 weeks following the final RF treatment. RESULTS: A statistically significant improvement was found in the overall appearance on both sides treated with the RF device when compared to baseline. However, the area treated with the topical agent showed a statistically significantly greater degree of improvement than the side where no topical agent was applied. No adverse effects were reported. CONCLUSION: The use of a novel skin tightening agent used after RF procedures is both safe and effective for treatment of skin laxity on the buttocks and thighs. Combined therapy leads to a better result.

Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study.

BACKGROUND: Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic for patients with psoriatic arthritis (PsA). Given that many patients with PsA are TNFi inadequate responders (TNF-IR; either inadequate efficacy or intolerance), treatments utilizing alternative mechanisms of action are needed. In phase 3 studies, the fully human interleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in patients with active PsA, including TNFi-IR. Efficacy was generally consistent between TNFi-naïve and TNFi-experienced cohorts; however, in the latter, higher response rates have been observed with the Q4W dosing regimen relative to the Q8W dosing regimen for some endpoints, suggesting the need to evaluate whether more frequent dosing may provide an incremental clinical benefit for TNFi-IR patients. METHODS: The phase 3b SOLSTICE study will assess guselkumab efficacy and safety in TNFi-IR PsA patients. Eligibility criteria include a PsA diagnosis for ≥ 6 months; active disease (≥ 3 swollen, ≥ 3 tender joints, C-reactive protein ≥ 0.3 mg/dL); and inadequate efficacy with, and/or intolerance to, one prior TNFi. Participants will be randomized 1:1:1 to guselkumab Q4W or Q8W or placebo→guselkumab Q4W (at Week 24). The primary endpoint is the proportion of patients achieving ≥ 20% improvement in the American College of Rheumatology criteria (ACR20) at Week 24. Major secondary endpoints include ACR50, ACR70; an Investigator's Global Assessment (IGA) of psoriasis score of 0/1 plus ≥ 2-grade reduction and ≥ 90% improvement in Psoriasis Area and Severity Index (both among patients with ≥ 3% body surface area affected by psoriasis and baseline IGA ≥ 2); minimal/very low disease activity; and changes from baseline in Health Assessment Questionnaire-Disability Index, the 36-item Short-Form Health Survey Physical Component Summary, and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The target sample size (N = 450) is estimated to provide > 90% power in detecting differences between each guselkumab group and the placebo group for the primary endpoint assuming a 2-sided α = 0.05. Cochran-Mantel-Haenszel testing and analyses of covariance will be used to compare efficacy for binary and continuous endpoints, respectively. DISCUSSION: Findings from the phase 3b SOLSTICE study, the design of which was informed by results from previously conducted phase 3 studies, is expected to provide important efficacy and safety information on guselkumab therapy in TNFi-IR patients with PsA. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov, NCT04936308, on 23 June 2021.

Resveratrol: a unique antioxidant offering a multi-mechanistic approach for treating aging skin.

Resveratrol is a botanical antioxidant with diverse biologic effects. In this paper we will review the unique antioxidant activity of resveratrol including its effects on mitochondrial function. The molecular signaling of resveratrol and cellular mechanisms that make this botanical active an important anti-aging ingredient for topical application will be discussed.

Vitamin C Compound Mixtures Prevent Ozone-Induced Oxidative Damage in Human Keratinocytes as Initial Assessment of Pollution Protection.

INTRODUCTION: One of the main functions of cutaneous tissues is to protect our body from the outdoor insults. Ozone (O3) is among the most toxic stressors to which we are continuously exposed and because of its critical location, the skin is one of the most susceptible tissues to the oxidative damaging effect of O3. O3 is not able to penetrate the skin, and although it is not a radical per se, the damage is mainly a consequence of its ability to induce oxidative stress via the formation of lipid peroxidation products. AIM OF STUDY: In this study we investigated the protective effect of defined "antioxidant" mixtures against O3 induced oxidative stress damage in human keratinocytes and understand their underlying mechanism of action. RESULTS: Results showed that the mixtures tested were able to protect human keratinocytes from O3-induced cytotoxicity, inhibition of cellular proliferation, decrease the formation of HNE protein adducts, ROS, and carbonyls levels. Furthermore, we have observed the decreased activation of the redox sensitive transcription factor NF-kB, which is involved in transcribing pro-inflammatory cytokines and therefore constitutes one of the main players associated with O3 induced skin inflammation. Cells exposed to O3 demonstrated a dose dependent increase in p65 subunit nuclear expression as a marker of NF-kB activation, while pre-treatment with the mixtures abolished NF-kB nuclear translocation. In addition, a significant activation of Nrf2 in keratinocytes treated with the mixtures was also observed. CONCLUSION: Overall this study was able to demonstrate a protective effect of the tested compounds versus O3-induced cell damage in human keratinocytes. Pre-treatment with the tested compounds significantly reduced the oxidative damage induced by O3 exposure and this protective effect was correlated to the abolishment of NF-kB nuclear translocation, as well as activation of Nrf2 nuclear translocation activating the downstream defence enzymes involved in cellular detoxification process.

Dyspigmentation, skin physiology, and a novel approach to skin lightening.

BACKGROUND: Even facial pigmentation is considered a universal sign of youth and beauty in all cultures and at all ages in both men and women. The recent FDA concern about the safety of topical hydroquinone has provided the impetus for research into new pigment lightening alternatives in the cosmetic OTC market. AIM: This research examined a novel hydroxyphenoxy propionic acid, ellagic acid, yeast extract, and salicylic acid formulation applied twice daily compared to the standard prescription combination of 4% hydroquinone cream and 0.025% tretinoin cream applied nightly. METHOD: This single-center investigator-blinded 12 week study enrolled 82 subjects (7 male, 75 female) ages 25-60 years divided into 2 balanced groups of 41 subjects each with one group using a novel hydroxyphenoxy propionic acid, ellagic acid, yeast extract, and salicylic acid formulation applied twice daily compared to the standard prescription combination of 4% hydroquinone cream and 0.025% tretinoin cream applied nightly. RESULTS: Significant tolerability issues arose with the prescription combinations that were not seen with the cosmetic formulation. In terms of ability to even skin tone, decrease spot intensity, decrease spot size, and improve overall pigmentation, both products demonstrated parity. CONCLUSION: This research demonstrated the value of cosmetic formulations as part of a treatment regimen for pigmentation issues.