INDIVIDUAL ARTICLE: Sugar Sag: What Is Skin Glycation and How Do You Combat It?

Skin aging is influenced by various exogenous and endogenous factors, ranging from ultraviolet (UV) light exposure and environmental toxins to biological sources, such as those that arise from normal metabolic processes (eg, free radicals). Glycation is the normal process by which glucose and other reducing sugars react with proteins to form an array of heterogeneous biomolecular structures known as advanced glycation end-products (AGEs) over time. However, AGEs are toxic to human cells and are implicated in the acceleration of inflammatory and oxidative processes, with their accumulation in the skin being associated with increased skin dulling and yellowing, fine lines, wrinkles, and skin laxity. Clinicians should become cognizant of how AGEs develop, what their biological consequences are, and familiarize themselves with available strategies to mitigate their formation. J Drugs Dermatol.  2024;23:4(Suppl 1):s5-10.

INDIVIDUAL ARTICLE: Efficacy of a Prebiotic Skincare Regimen on Improving Mild Atopic Dermatitis and Severe Xerosis in Diverse Ethnically Patients.

Atopic Dermatitis (AD) is a chronic relapsing inflammatory skin disease associated with a significant patient burden on quality-of-life. Given skin barrier including skin microbiome changes are linked to AD pathogenesis, prebiotic emollients are shown to improve disease symptoms and maintain skin barrier integrity, normalizing skin microbiota. In this study, we evaluated the efficacy and safety of a prebiotic skincare routine in improving AD and xerosis, and ultimately quality-of-life in ethnically diverse patients. A total of 140 subjects from different racial/ethnic backgrounds, aged 3-80 years old with skin phototypes I-VI, and presenting with mild-AD or severe xerosis completed study. Expert grading, instrumentation, self-assessment questionnaires, plus clinical imaging demonstrated that a prebiotic cleanser and moisturizer routine significantly reduced skin conditions severity, strengthened skin barrier properties in both lesional and normal skin, and improved patients' quality-of-life while providing itch relief as soon as 4 weeks. The results of this research indicate that a prebiotic cleanser and moisturizer regimen offers benefits for diverse patient’s daily skincare routine by effectively managing AD and xerosis severity and symptoms, normalizing skin microbiota, plus preserving skin barrier integrity to prevent long-term sequelae. J Drugs Dermatol. 2024;23:3(Suppl 2):s12-22.

INDIVIDUAL ARTICLE: Atopic Dermatitis Skincare and Impact on Quality of Life for Patients with Skin of Color.

Atopic Dermatitis (AD) epidemiologic studies report a higher incidence and prevalence among populations with skin of color (SOC). Additionally, differences in AD underlying gene mutations and skin morphology are observed to lead to frequent and prominent xerosis, pruritus, and pigmentary sequelae in patients of color. However, populations with SOC are underrepresented in dermatology clinical trials, including AD. This article reviews the nuances in AD epidemiology, clinical presentation, and impact on quality-of-life among populations with SOC, plus highlight the role of skincare in AD management. J Drugs Dermatol. 2024;23:3(Suppl 2):s6-11.

Image Analysis of Xerosis and Atopic Dermatitis Following Prebiotic Skincare Regimen in Ethnically Diverse Patients.

Variations in the epidemiology, clinical presentation, and disease course in atopic dermatitis (AD) patients with Skin of Color (SOC) compared with white counterparts have been reported. In this study, we evaluated the capability of a new imaging device (SkinCam) in quantifying skin texture changes in diverse patients, presenting with AD or xerosis, after using a prebiotic skincare routine over 10 weeks.  A total of 39 subjects from diverse racial/ethnic backgrounds, aged 3 to 76 years old, with Fitzpatrick skin phototypes I to VI, presenting with mild AD and moderate to severe xerosis, were enrolled in the study. All subjects used a prebiotic cleanser on its own for 2 weeks, followed by a prebiotic moisturizer in conjunction for an additional 8 weeks. Standardized images of the subjects' legs were taken with SkinCam at several time points (baseline, week 2, and week 10), and analyzed for skin texture parameters. Our results demonstrate that both skin texture irregularity and skin color patterns significantly improve over time with a prebiotic skincare regimen in AD (n=12) and xerosis (n=24) subjects. Interestingly, image analyses showed more improvement over time in xerosis and AD SOC patients (n=18, Fitzpatrick IV-VI). Lastly, skin texture analyses from SkinCam imaging correlated with clinical assessments, showing significant improvement by prebiotic skincare regimen in all subjects by week 10. In summary, our results demonstrate that the SkinCam imaging device has the capability to effectively monitor skin texture parameters over time in both AD and xerosis patients with lightly and darkly pigmented skin. J Drugs Dermatol. 2024;23(7):557-563.  doi:10.36849/JDD.8371.

Ceramide-Containing Adjunctive Skin Care for Skin Barrier Restoration During Acne Vulgaris Treatment.

Barrier damage caused by facial acne vulgaris can be magnified by topical medication, such as adapalene (0.3%) and benzoyl peroxide (2.5%)(A/BPO), which utilizes a retinoid to normalize follicular keratinization and BPO to decrease the C. acnes population. Disease-induced irritation combined with topical medication-induced irritation results in dryness and enhanced inflammation leading to lower compliance and increased skin healing time. Ceramide-based moisturizers have documented barrier repair benefits for eczema but have not been studied for acne. The objective of this double-blind study was to measure the impact of acne treatment on skin barrier function and tolerance when paired with a ceramide routine. Participants were prescribed an A/BPO gel once daily. The treatment group received a ceramide-containing foaming facial cleanser and facial lotion, and the control group received basic foaming face wash for twice-daily use. Participant and investigator tolerability and efficacy were evaluated by both ordinal and clinical measures. Acne lesion counts and Investigator’s Global Assessments (IGA) of acne were obtained along with transepidermal water loss (TEWL) measurements for barrier function. TEWL for the treatment group remained significantly lower than the control at all timepoints and significantly improved from baseline by week 12. The treatment group had statistically lower mean investigator scores for dryness at all timepoints. Inflammatory lesion counts were significantly lower for the treatment group. A/BPO damaged the skin barrier, demonstrated by elevated TEWL, contributing to dryness, redness, and scaling. Use of a ceramide-containing cleanser and moisturizer significantly reduced severity and incidence of dryness, erythema, and scaling while more quickly resolving barrier damage and restoring function. Draelos ZD, Baalbaki N, Colon G, et al. Ceramide-containing adjunctive skin care for skin barrier restoration during acne vulgaris treatment. J Drugs Dermatol. 2023;22(6):554-558. doi:10.36849/JDD.7142 .

Vehicle Effects on the Rosacea Skin Barrier.

BACKGROUND: Inflammatory papulopustular rosacea produces sensitive facial skin. Thus, medications designed for rosacea require careful vehicle development to insure optimal drug delivery in an environment suitable for barrier repair. OBJECTIVE: The objective of this phase 1 study was to elucidate the barrier effects of an investigational topical minocycline anhydrous gel 3% in subjects with inflammatory rosacea. METHODS: 31 male or female subjects with all complexion types and moderate facial rosacea, defined as 15+ inflammatory facial lesions, were enrolled in this single-site study to evaluate the effects of an investigational topical 3% minocycline anhydrous gel vehicle on skin barrier function; the new topical minocycline gel is an investigational product under development and has completed a phase 2b study in rosacea patients. Following a 30-minute acclimation period, subjects underwent a one-minute transepidermal water loss (TEWL) measurement on the left cheek and triplicate pin probe corneometry measurements from the right cheek. Subjects used the investigational topical 3% minocycline anhydrous gel every evening and returned to the research center at day 1, week 2, and week 4. RESULTS: 30/31 subjects completed the research study. The study medication produced a 23% (P=0.003) increase in skin hydration at day 1 and maintained the hydration increase with a 22% (P=0.003) increase at week 2 and a 20% increase (P=0.001) at week 4. Simultaneously, skin barrier function also improved with an 11% reduction in TEWL at day 1 followed by an 18% reduction in TEWL at week 2 (P=0.001) and a 28% decrease in TEWL at week 4 (P<0.001). This improvement in skin barrier was due to a combination of skin healing and the moisturizing properties of the investigational topical 3% minocycline anhydrous gel medication evaluated in this study. CONCLUSION: The investigational topical 3% minocycline anhydrous gel decreases TEWL, indicating barrier repair, while increasing corneometry measurements, indicating improved skin hydration. J Drugs Dermatol. 2021;20(6):630-632. doi:10.36849/JDD.6105Visit the rosacea resource center.

Revisiting the Skin Health and Beauty Pyramid: A Clinically Based Guide to Selecting Topical Skincare Products.

The original article “The Skin Health and Beauty Pyramid” was published in 2014. In the last 7 years, many new skin care innovations have been developed that were not available at the time of the first publication. New mechanisms of action for recently identified unmet skin aging needs along with novel ingredients have been commercialized that warrant the attention of dermatologists, skin care professionals, and patients. This article updates the original pyramid with these new concepts. J Drugs Dermatol. 2021;20(6):695-699. doi:10.36849/JDD.5883 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL fTEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Clinical Evidence of Cell-Targeted Topical Therapy for Treating Skin Dyspigmentation.

BACKGROUND: New development of cell-targeted therapies to enable site-specific skin tissue drug delivery may reduce off-target effects, decrease unwanted toxicities, and enhance drug efficacy. These efforts have led to several targeting strategies that modulate active product delivery to include small molecule-, nucleic acid-, peptide-, antibody-, and cell-based strategies. Tissue specific cell-targeting strategies such as these may be useful in cosmetic dermatologic applications. OBJECTIVE: The aim of this 16-week clinical trial of a skin brightening composition containing melanocyte cell-targeted biodelivery was to assess its effectiveness in restoring the skin complexion evenness by modulating melanocyte activity in a cohort of 50 Fitzpatrick type I–VI subjects with moderate to severe dyspigmentation. RESULTS: Data from expert grading, skin surface colorimetry, and subject self-assessments reflected significant improvement in facial skin tone as early as 2 weeks after treatment initiation, with continual improvement through week 16. The most dramatic pigmentation improvement, based on investigator assessments, was a statistically significant improvement in skin brightness at week 2 that progressed to week 8 with significant improvement in skin evenness and brightness. By weeks 12 and 16, progressive levels of significant improvement in skin evenness and brightening became apparent. Colorimetry demonstrated progressive improvement in skin dyspigmentation starting at 2 weeks and continuing to week 16. Subject self-assessment data supported similar improvements in skin dyspigmentation. CONCLUSION: These results demonstrate the ability of a cell-targeted topical therapy to achieve improvements in skin pigmentation through site-specific suppression of melanocyte activity. J Drugs Dermatol. 2021;20(8):865-867. oi:10.36849/JDD.6037 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL fTEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Oral Sarecycline for Treatment of Papulopustular Rosacea: Results of a Pilot Study of Effectiveness and Safety.

BACKGROUND: Cutaneous rosacea is a common inflammatory skin disorder that often presents with facial papulopustular lesions that are frequently bothersome to patients. Studies have shown oral sarecycline to be effective and safe for acne, with a low risk of side effects that are historically associated with other tetracycline-class drugs such as doxycycline and minocycline, in addition to offering a reduced risk of emergence of resistant bacteria due to its narrow-spectrum of antibiotic activity. Oral sarecycline is FDA-approved for the treatment of acne (2018). OBJECTIVE: A pilot study to evaluate the efficacy and safety of oral sarecycline in papulopustular rosacea. METHODS: A 12-week, prospective, parallel-group, investigator-blinded, controlled pilot study was completed evaluating once-daily sarecycline, using weight-based oral dosing as recommended for acne vs control (multivitamin tablet), for the treatment of moderate-to-severe papulopustular rosacea in adult subjects (n=102), aged ≥18 years. The primary efficacy endpoint was Investigator's Global score (IGA; clear or almost clear) and percent reduction in inflammatory lesion count at week 12. Safety and tolerability assessments were performed as well. RESULTS: A total of 102 subjects were randomized; 97 completed the study. At week 12, IGA improvement was significantly greater for oral sarecycline when compared to the control (P<0.0001). Furthermore, absolute and percent reductions in inflammatory lesion counts were significantly greater in the sarecycline group for all weeks (4, 8, and 12) when compared to the control (P<0.001). Significant improvement in facial burning, erythema, and pruritus was reported in the sarecycline group, when compared to the control (P<0.05). No serious AEs were reported. CONCLUSION: Sarecycline was effective, safe, and well-tolerated for treating papulopustular rosacea in adults with marked superiority in efficacy compared to subjects in the control group. With its narrow-spectrum activity, oral sarecycline may be a good option for the treatment of papulopustular rosacea. Additional studies are warranted to confirm the positive results of this pilot study.

Novel Facial Treatment Regimen Improves Aging Skin Appearance.

BACKGROUND: Skin care regimens with multiple active ingredients offer a multimodal approach to anti-aging treatments. OBJECTIVE: The objective of this research was to investigate the efficacy of a multimodal skincare regimen on facial skin appearance after 12 weeks of twice daily use as compared to baseline. METHOD: 35 healthy female subjects 35–65 years of age of Fitzpatrick skin types I–III with mild to moderate facial photoaging characterized by hyperpigmentation were enrolled. Subjects were seen at baseline, week 6, and week 12, and underwent subject and investigator assessments along with noninvasive evaluations (elasticity, corneometry, dermaspectrophotometer) and photography. RESULTS: Most notable at week 12 was a 60% improvement in smoothness, 82% improvement in dryness, 30% improvement in fine lines, and 24% improvement in crow’s feet. There was an 8% reduction in macule hyperpigmentation (P<0.001) at week 12, supporting excellent pigment lightening qualities for the regimen. There was a statistically significant increase in skin firmness (decrease in elasticity) as early as week 6 of 6% with further improvement observed at week 12 of 16% (P=0.002). SUMMARY: A multimodal skincare regimen with antioxidants, retinol, hydrolyzed pearl, caviar extract, peptides, and growth factors including EGF and TGF-β results in an improvement in the appearance of photoaged skin after 12 weeks of twice daily use. J Drugs Dermatol. 2021;20(3):274-278. doi:10.36849/JDD.5791.

The First of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into 5 target glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety was evaluated throughout the study. RESULTS: The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was first established in this early phase II study based on a broad range of outcomes.

The Second of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as independently assessed by both investigator and patient on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment (IT) of 20 U prabotulinumtoxinA (4 U/0.1 mL final vacuum-dried formulation injected into 5 glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety outcomes were evaluated throughout the study. RESULTS: The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug-related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Eight patients (1.4%) experienced study drug-related AEs of special interest: 5 experienced eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none were study drug related. A total of 4060 serum samples were tested for antibotulinum toxin antibodies; no seroconversion was observed. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was confirmed in this second phase II study based on a broad range of outcomes.

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.

OBJECTIVE: 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. METHOD: Forty-five photoaged females ages 35-65, Fitzpatrick skin types I-IV, with moderate wrinkling were enrolled in the 12-week study. A step-up protocol for increasing the dose of retinol serum (0.25%, 0.5%, 1.0%) or tretinoin cream (0.025%, 0.05%, and 0.1%) in combination with a test moisturizer or currently marketed dermatologist-recommended moisturizing cream was used. Overall severity of investigator graded photodamage, subject assessed photodamage, and tolerability criteria were evaluated using a 5-point ordinal scale at weeks 4, 8, and 12. Facial photography occurred at each visit and TEWL was measured at baseline and week 12. Histologic evaluation of punch biopsies was completed on baseline and week 12 samples. RESULTS: After 12 weeks of use, both retinol serum and tretinoin demonstrated parity across investigator and subject assessment measurements as well as diagnostic measures including TEWL. Retinol serum subjects showed significant week 4 improvement in visual skin smoothness compared to tretinoin subjects (P=0.031). There was highly significant improvement in skin dryness with the retinol serum (P<0.001) not seen in the tretinoin group. Histologic analysis of baseline and 12-week punch biopsies demonstrated newly formed collagen and greater epidermal thickening in retinol serum subjects compared to tretinoin treated subjects. CONCLUSION: Retinol serum (0.25%, 0.5%, 1.0%) was safe and effective with equivalent/or better performance and tolerability than tretinoin creams. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.5085.

Development of a Photonumeric Lip Health Scale.

BACKGROUND: The lips are important facial anatomic features with particular vulnerability to environmental damage, yet they have received little attention in the dermatologic literature. A photonumeric rating scale for clinically assessing lip heath is needed to advance lip research. OBJECTIVE: To develop a photonumeric lip health assessment scale for clinical use that can evaluate the efficacy of products for improving lip health. METHODS: The VISIA®-CR 4.3 system was used to photograph the frontal face of 103 subjects with Fitzpatrick skin types I–III exhibiting a range of lip health status based on the key characteristics of lip shine, texture, and vermilion border. An expert panel comprising 3 dermatologists independently rated the images based on the proposed rating scale. Images with ≥75% rater agreement were redistributed to the panel for selecting the final images and verification of the final scale. RESULTS: The panel selected 15 images for the final scale: 5 for each of the key characteristics (lip shine, texture, and vermilion border) and 1 for each ordinal rating of 0–5 within a characteristic (eg, 0=very shiny, 5=very dull). All of these images achieved 100% agreement among the raters. CONCLUSION: This scale provides healthcare professionals and researchers a way to evaluate current lip health, track improvement, and evaluate the efficacy of treatments. It can be used to communicate with patients during discussions about lip conditions, recommending treatments, and setting goals. The scale also provides a research tool to evaluate different formulations for developing lip care products. J Drugs Dermatol. 2020;19(6):   doi:10.36849/JDD.2020.5139.

Demonstration of the Antioxidant Capabilities of a Product Formulated With Antioxidants Stabilized in Their Reduced Form

Oxidative damage from reactive oxygen species is instrumental in aging. Topical antioxidants are used in many cosmeceuticals to provide appearance benefits; however, the activity of these antioxidants may be questionable. This research validated the activity of L-ascorbic acid and L-glutathione in the studied facial product and correlated this activity with clinical appearance improvement following 12 weeks of use. J Drugs Dermatol. 2020;19(1):46-49. doi:10.36849/JDD.2020.3947

Clinical Evaluation of a Nature-Based Bakuchiol Anti-Aging Moisturizer for Sensitive Skin.

BACKGROUND: Patients with sensitive skin find topical retinoid use for anti-aging purposes challenging due to irritation. Bakuchiol, a meroterpene from the Psoralea corylifolia seed, has retinol functionality through retinol-like regulation of gene expression. OBJECTIVE: This research examined the tolerability, efficacy, and barrier effects of a nature-based bakuchiol-containing cleanser and moisturizer in subjects with sensitive skin. METHODS: 60 female subjects Fitzpatrick skin types I–V age 40–65 years with sensitive mild to moderate photodamaged skin were enrolled in this 4 week study. A sensitive skin panel was constructed: 1/3 eczema/atopic dermatitis, 1/3 rosacea, 1/3 cosmetic intolerance syndrome. Subjects used a nature-based cleanser and moisturizer twice daily and underwent transepidermal water loss (TEWL), corneometry, tolerability assessments, and efficacy assessments at baseline, 5–10 minutes post-application, and week 4. RESULTS: The skin care products were well tolerated and efficacious (P<0.001) in terms of investigator assessed improvement in visual smoothness, tactile smoothness, clarity, radiance, overall appearance, and global anti-aging. Cheek corneometry measurements demonstrated a statistically significant 16% increase in skin moisture content (P<0.001). CONCLUSION: A bakuchiol nature-based anti-aging moisturizer is well tolerated and effective in individuals with sensitive skin.J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.5522.

The Role of Platelet Homeostasis in a Novel Topical PRP Formulation.

BACKGROUND: Topical platelet-rich plasma (PRP) must demonstrate stability to insure biologic activity in aesthetic medicine. OBJECTIVE: The objective of this research was to evaluate the role of platelet homeostasis in a novel PRP topical cosmetic formulation to provide facial appearance improvement. METHODS: The stability of the topical PRP formulation was evaluated in vitro followed by clinical in vivo testing. The in vitro evaluation examined platelet stability and morphology over a 90-day period within the preservative cosmetic base utilizing ELISA and light microscopy (LM)/scanning electron microscopy (SEM). The in vivo clinical study enrolled 20 subjects in a 120-day double blind split face study to evaluate the effect of 5–7x concentrated PRP compared to 2–3x concentrated PRP on facial photoaging. Cosmetic effect was evaluated by the subject and the dermatologist investigator on a 5-point ordinal scale at baseline, week 8, and week 16. RESULTS: 90-day stability for the topical PRP formulation was verified via ELISA and LM/SEM. ELISA showed the PRP was more inactive than control conditions via analyte concentration curves (PDGF-AB, EGF, and P-Selectin). LM/SEM demonstrated the PRP had less aggregation/activation over time within the cosmetic base and that refrigeration is superior to room-temperature storage thus delaying full platelet degranulation. The in vivo clinical study demonstrated parity between 20ml and 60ml PRP in terms of clinical efficacy. CONCLUSION: Platelets remain viable for up to 90 days in a refrigerated cosmetic vehicle with demonstrated topical clinical PRP facial benefits. PRP kits of 20ml and 60ml volumes for topical PRP are equally efficacious. J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.5495.

Clinical Benefits of Circadian-based Antioxidant Protection and Repair.

Skin activities follow endogenous circadian rhythms resulting in differences between daytime and nighttime properties. To address the variations in skin needs, a novel circadian-based dual serum system (LVS) was developed. A 12-week, double-blind, randomized, regimen-controlled, multi-center study was conducted to assess the efficacy and tolerability of LVS on subjects presenting with moderate-severe photodamage. 61 Female subjects (36–65 years; Fitzpatrick skin types I–VI) completed the study. The active group received LVS (daytime serum and nighttime serum) and basic skin care regimen (moisturizer and SPF 35 sunscreen), while the control group received the basic skin care regimen only. In addition to clinical grading, subject self-assessment questionnaires, and standardized photography, punch biopsies were taken in a subset of subjects for immunohistochemistry. Additionally, swab samples were taken for skin surface oxidation analysis. Significant improvements over control were observed in the active group in Radiance (weeks 4, 8, and 12), Overall Photodamage, Tactile Toughness, and Global Fine Lines/Wrinkles (week 12). Biopsy results, skin swab analysis and standardized photographs support the clinical grading findings. At all follow-up visits, LVS was consistently highly rated over control by subjects, with a significant proportion of subjects agreeing at week 12 that LVS “improved the radiance of my skin,” and “improved the overall health and look of my skin”. Results from this study suggest that LVS may provide essential protective and reparative effects to skin exposed to the damaging effects of environmental factors, and also demonstrates the value of including skin circadian rhythm-based concepts in a topical skincare regimen. J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.5355.

A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies.

BACKGROUND: FMX101 4% is a topical minocycline foam for the treatment of moderate-to-severe acne. OBJECTIVE: Evaluate the efficacy and safety of FMX101 4% in treating moderate-to-severe acne vulgaris. METHODS: Two identical phase 3 studies were conducted. Subjects were randomized 2:1 to once-daily FMX101 4% or foam vehicle for 12 weeks. The coprimary end points were the change in inflammatory lesion count from baseline and the rate of treatment success according to the Investigator's Global Assessment (a score of 0 or 1 for clear or almost clear, with a ≥2-grade improvement) at week 12. RESULTS: A total of 961 subjects were enrolled (study 04, N = 466; study 05, N = 495). Compared with vehicle, FMX101 4% demonstrated a significantly greater reduction in inflammatory lesions in both studies (P < .05) and a greater rate of treatment success in study 05 according to the Investigator's Global Assessment (P < .05). Pooled analyses of the 2 studies demonstrated statistical significance for both coprimary end points (all P < .05). Noninflammatory lesion count was also significantly reduced with FMX101 4% versus with vehicle in both studies. FMX101 4% was generally safe and well tolerated. Skin-related adverse events were reported in less than 1% of subjects treated with FMX101 4%. LIMITATIONS: Longer-term efficacy and safety outcomes are needed (ongoing). CONCLUSION: FMX101 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved Investigator's Global Assessment scores in patients with moderate-to-severe acne.

A Novel Approach to Enhancing the Quality and Appearance of Photoaged Skin

Background: Moisturizers create the illusion of smooth, soft skin by placing a temporary film over the skin surface or by imparting a transient hydration benefit that does not clinically improve the quality or appearance of skin. Objective: The objective of this 8-week study was to assess the clinically relevant effects of a 3-step facial treatment program to improve the multiple qualities of photoaged skin. Methods: Thirty-five female subjects were evaluated at baseline and after 2, 4, and 8 weeks. Measures included investigator and subject assessments and noninvasive measures of skin hydration, elasticity, sebum, and exfoliation. Results: This novel approach resulted in significant objective, subjective, and bio-instrumental improvements in the appearance and quality of photoaged skin. At the end of the study, the investigator efficacy assessments demonstrated significant reduction in roughness, sebum, redness, and dirt with improvement in skin dryness, moisturization, clarity, smoothness, softness, radiance, and overall appearance without use of a moisturizer. The treatment products were well-tolerated. Conclusion: Use of this novel approach safely and effectively improved multiple clinical endpoints of photoaged skin through cleansing, aggressive exfoliation, and sebum reduction in the absence of a traditional moisturizer. J Drugs Dermatol. 2019;18(1):28-31.