Efficacy and Tolerance of a Polymeric Surfactant Technology-Based Cleanser for Clinically Diagnosed Sensitive Skin.

BACKGROUND: Cleansing is an important hygiene activity, necessary to prevent bacterial, fungal, yeast, and viral infection. However, in the presence of skin disease, cleansing can take on a new challenge: removing the sebum, sweat, externally applied substances, environmental debris, and organisms from the face without damaging the skin barrier. Since cleansers cannot easily distinguish between sebum and the intercellular lipids required to maintain skin integrity, unique cleansing technologies are necessary to provide mild cleansing for the many manifestations of sensitive skin. OBJECTIVE: This 4-week clinical study aimed to evaluate the appropriateness of a cosmetic facial foaming gel cleanser with a polymeric surfactant technology in a diverse sensitive skin population. METHOD: 85 subjects with sensitive skin due to eczema/atopic dermatitis, rosacea, acne, or cosmetic intolerance syndrome were evaluated via investigator grading, self-assessment questionnaire, noninvasive measurements, and digital photography. RESULTS: The foaming gel cleanser was well tolerated showing no significant increases in investigator-graded irritation endpoints. Sensitive skin subjects saw considerable reduction (P<0.05) in stinging, itching, burning, tightness, and overall sensitivity at 2 and 4 weeks. Improvements in smoothness, softness, clarity, radiance, and overall skin appearance, were observed by both the investigator and patients (P<0.05) at 2 and 4 weeks. CONCLUSION: The polymeric surfactant technology-based foaming gel cleanser provided a rich, foaming lather that felt gentle and left skin feeling comfortable. J Drugs Dermatol. 2024;23(10):889-893. doi:10.36849/JDD.8510.

Assessment of the Vehicle for Roflumilast Cream Compared to a Ceramide-Containing Moisturizing Cream in Mild Eczema.

BACKGROUND: Inflammatory dermatologic conditions suitable for topical treatments benefit from a hydrating vehicle that improves the skin barrier without irritation. OBJECTIVE: This research was designed to assess skin barrier effects and aesthetic attributes of the vehicle for topical roflumilast cream (vehicle) vs a currently marketed ceramide-containing moisturizing cream (moisturizer). METHODS: This was a single-site, randomized, intraindividual, double-blind, controlled study conducted over 17 days. Patients (aged 18 years or older) with mild, symmetric asteatotic eczema of the lower extremities were enrolled to receive lower leg applications of the vehicle on one leg and moisturizer on the other. The primary efficacy endpoint was a change in transepidermal water loss (TEWL) from baseline to day 15. Secondary efficacy endpoints included change from baseline in TEWL at other study visits, change from baseline in hydration as assessed via corneometry, and patient- and investigator-rated assessments of the products. Safety and tolerability were also assessed. RESULTS: A total of 40 patients enrolled in the study. The primary efficacy endpoint was met for both treatments. A statistically significant difference in TEWL on day 1 favored the moisturizer, but no difference was seen between vehicle and moisturizer at any other timepoint. Both vehicle and moisturizer also met the secondary efficacy endpoint of change from baseline in hydration. LIMITATIONS: The sample size was small. CONCLUSIONS: The vehicle for roflumilast cream performed similarly to a leading, currently marketed, dermatologist-recommended, ceramide-containing moisturizer across all patient- and investigator-rated assessments of efficacy, tolerability, and aesthetic properties in patients with mild asteatotic eczema. J Drugs Dermatol. 2024;23(10):834-840. doi:10.36849/JDD.7958  .

Application Characteristics and Patient Preference of Triple-Combination vs Layered Topicals for Acne: Split-Face Study.

BACKGROUND: Although triple-combination therapies for acne are generally more efficacious than dual-combinations or topical monotherapy, this benefit may be offset by reduced adherence to a complicated treatment regimen. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB; Cabtreo®, Ortho Dermatologics) gel is the first triple-combination topical approved for the treatment of acne. By delivering multiple active ingredients as a fixed-dose combination, CAB gel may improve ease of use, which can benefit both treatment adherence and efficacy. The objective of this study was to compare the application characteristics of CAB gel with the layered application of its 3 individual active ingredients. METHODS: In this split-face study, adults with acne-prone skin (N=25), self-applied CAB gel (0.3 cc) to 1 side of the face and layered benzoyl peroxide cream, adapalene gel, and clindamycin gel (0.1 cc each) on the opposite side. CAB and clindamycin gels were compounded with pyranine, which fluoresces under blue light. Photos taken under blue light were used to assess the uniformity of product application, and participants rated the evenness, speed, and ease of the 2 application regimens, as well as overall preference. RESULTS: Investigator-assessed evenness of application favored CAB gel over layered application in 100% of participants. All participants rated the application of CAB gel as more uniform, easier, and faster. Most (96%) preferred CAB gel for use at home. CONCLUSION: Fixed-dose CAB gel was applied more evenly than separate application of its 3 active ingredients. By addressing 3 of the main acne pathogenic pathways in a single, easy-to-apply formulation, CAB gel may improve the efficacy of and adherence to acne treatment. J Drugs Dermatol. 2024;23(10):857-861. doi:10.36849/JDD.8430.

A Novel Protection and Repair Skincare Regimen Shows Efficacy for Improving Environmental Skin Aging.

BACKGROUND: Skin aging is accelerated by environmental exposures including solar radiation and pollutants. Thus, protecting skin from environmental exposure and repairing ensuing damage is essential for keeping skin healthy and appearing youthful. PURPOSE: To evaluate the clinical benefits of a novel skincare regimen designed to provide comprehensive environmental protection in the daytime and repair environmentally damaged skin at night. METHODS: Thirty participants, including males and females, with mild-to-moderate extrinsic aging, were enrolled in a 12-week single-site study. Participants used the regimen (The Essential Six, RATIONALE, Victoria, Australia) comprised of 3 products to protect the skin in the morning and 3 products to repair the skin at night. Participants were seen at baseline and evaluated for efficacy and tolerability at weeks 2, 6, and 12. Non-invasive measurements to evaluate hydration, transepidermal water loss, skin tone, and elasticity were conducted. RESULTS: The dermatologist investigator noted across-the-board improvement in all evaluated parameters, except deep wrinkles. By week 12, there were statistically significant (P<0.001) improvements in radiance (43%), tactile roughness (48%), visual roughness (44%), firmness (32%), clarity/even skin tone (21%), and overall appearance (29%). Fine lines improved 16% at week 12 (P=0.002). Participant self-assessment revealed statistically significant and progressive improvement in all evaluated parameters over time. No tolerability issues were identified by the investigator, while a small number of participants reported mild stinging and some dryness that resolved over time. This was likely due to the high concentration of active ingredients found in this regimen. Corneometry revealed improved skin hydration of 28% as early as week 2. CONCLUSION: The data presented confirms that this novel protection and repair regimen improves the appearance of environmentally aged skin. J Drugs Dermatol. 2024;23(10):866-872. doi:10.36849/JDD.8274.

A Cosmetic Regimen Formulated to Address the Multi-Modal Pathogenesis of Rosacea Demonstrates Efficacy for Treating Facial Redness and Skin's Appearance.

BACKGROUND: The treatment of rosacea is complicated as there are multiple pathogenic factors in play resulting in a myriad of clinical signs and symptoms including facial redness. OBJECTIVE: The primary objective was to evaluate the efficacy and tolerability of a non-prescription anti-redness regimen in patients with rosacea. METHODS: Thirty subjects with rosacea-induced facial erythema were enrolled in this single site, monadic study. The test regimen consisted of a treatment serum, redness-reducing moisturizer, and sunscreen. The test products are formulated with ingredients curated to address the multifactorial pathogenesis of facial redness. Investigator and subject self-assessment for efficacy and tolerability were performed at baseline, weeks 4 and 8. Non-invasive assessments for facial redness and skin hydration were conducted at all time points. RESULTS: Investigator grading showed significant improvement in facial redness of 21% at week 4 and 32% at week 8. Skin's appearance improved as early as 4 weeks while at 8 weeks there was statistically significant improvement in fine lines 15%, radiance/brightness 37%, tactile roughness 44%, visual roughness 41%, and 26% in overall appearance. Non-invasive assessments showed statistically significant improvement in skin hydration of 28% at week 4 and facial redness of 21% by week 8. No tolerability issues were identified by the investigator. CONCLUSION: Patients with rosacea often turn to over-the-counter products to reduce facial redness and improve skin's appearance. In this study, a cosmetic skincare regimen designed to reduce facial redness demonstrated efficacy and tolerability in subjects with rosacea. J Drugs Dermatol. 2024;23(9):757-763. doi:10.36849/JDD.8460.

Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials.

Importance: Safe, effective, and well-tolerated topical treatment options available for long-term use in patients with atopic dermatitis (AD) are limited and associated with low adherence rates. Objective: To evaluate efficacy and safety of once-daily roflumilast cream, 0.15%, vs vehicle cream in patients with AD. Design, Setting, and Participants: Two phase 3, randomized, double-blind, vehicle-controlled trials (Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis 1 and 2 [INTEGUMENT-1 and INTEGUMENT-2]), included patients from sites in the US, Canada, and Poland. Participants were 6 years or older with mild to moderate AD based on Validated Global Assessment for Atopic Dermatitis (assessed on a 5-point scale ranging from 0 [clear] to 4 [severe]). Intervention: Patients were randomized 2:1 to receive roflumilast cream, 0.15%, or vehicle cream once daily for 4 weeks. Main Outcomes and Measures: The primary efficacy end point was Validated Investigator Global Assessment for Atopic Dermatitis success at week 4, defined as a score of 0 or 1 plus at least a 2-grade improvement from baseline. Secondary end points included Eczema Area and Severity Index and Worst Itch Numeric Rating Scale. Safety and local tolerability were also evaluated. Results: Among 1337 patients (654 patients in INTEGUMENT-1 and 683 patients in INTEGUMENT-2), the mean (SD) age was 27.7 (19.2) years, and 761 participants (56.9%) were female. The mean body surface area involved was 13.6% (SD = 11.6%; range, 3.0% to 88.0%). Significantly more patients treated with roflumilast than vehicle achieved the primary end point (INTEGUMENT-1: 32.0% vs 15.2%, respectively; P < .001; INTEGUMENT-2: 28.9% vs 12.0%, respectively; P < .001). At week 4, statistically significant differences favoring roflumilast also occurred for the achievement of at least 75% reduction in the Eczema Area and Severity Index (INTEGUMENT-1: 43.2% vs 22.0%, respectively; P < .001; INTEGUMENT-2: 42.0% vs 19.7%, respectively; P < .001). Roflumilast was well tolerated with low rates of treatment-emergent adverse events. At each time point, investigators noted no signs of irritation at the application site in 885 patients who were treated with roflumilast (≥95%), and 885 patients who were treated with roflumilast (90%) reported no or mild sensation at the application site. Conclusions and Relevance: In 2 phase 3 trials enrolling adults and children, once-daily roflumilast cream, 0.15%, improved AD relative to vehicle cream, based on multiple efficacy end points, with favorable safety and tolerability. Trial Registration: ClinicalTrials.gov Identifiers: NCT04773587, NCT04773600.

The Clinical Efficacy of Lapachol in Facial Redness Reduction.

BACKGROUND: Facial erythema from acne, vascular rosacea, or photoaging is a common difficult-to-treat dermatologic challenge. OBJECTIVE: The objective of this study was to examine the role of lapachol in alleviating facial erythema associated with a variety of common dermatologic conditions. METHODS: Twenty-five healthy female and male subjects 35-65 years of age of Fitzpatrick skin types I-II with mild-to-moderate stable facial erythema from acne, rosacea or photoaging were enrolled in a single-site monadic study. Subjects received the study cream for twice daily application and were assessed at baseline, Week 4, and Week 8. The dermatologist investigator and subjects assessed efficacy and tolerability and facial photographic images were taken of all subjects at each visit. Noninvasive erythema assessments of the face were conducted using a colorimeter at baseline, Week 4, and Week 8 to document improvement in facial erythema. RESULTS: Twenty-five out of 25 subjects successfully completed the study without tolerability issues including 12 subjects with rosacea, 6 subjects with photoaging and 7 subjects with acne. After 8 weeks of use, the investigator rated a 44% decrease in facial erythema while the subjects rated a 40% decrease. Facial erythema was also noninvasively assessed with a colorimeter and dermaspectrophotometer (DSP). There was a 26% decrease in skin redness at Week 4 and a 31% decrease in skin redness at Week 8 on the colorimeter L*a*b* scale. This finding was collaborated by the DSP which registered a 29% decrease on the erythema scale at Week 8. CONCLUSION: Lapachol in a moisturizer formulation was found to be effective in reducing facial erythema from acne, rosacea, and photoaging.

Safety and Tolerance Evaluation of a Suncare Product in Ethnically Diverse Children With Atopic Dermatitis-Prone Skin

Atopic Dermatitis (AD) is a common chronic inflammatory skin condition, with high prevalence in children. Sun protection is important for children with eczema and AD-prone skin, yet many sunscreens can cause skin irritation due to their formulations. In this study, we evaluated the safety and tolerance of an SPF 50 sunscreen in ethnically diverse children with a history of AD over 4 weeks of product use. A total of 45 children from diverse racial/ethnic backgrounds, aged 3 to 12 years old with skin phototypes I-VI, plus a history of eczema and perceived sensitive skin completed the study. All participants applied sunscreen daily on the face and body, at least 15 minutes prior to sun exposure and as needed. After 4 weeks, evaluations were performed by a dermatologist and by participants for tolerability. Product performance questionnaires were also completed by parents/guardians of pediatric participants. After 4 weeks of sunscreen application, tolerability assessments of skin dryness, peeling, erythema, and edema were all absent in children participants. Parent/guardian evaluations of sunscreen tolerability for their child also revealed no perceived skin issues. These results were consistent with no adverse event being observed throughout the study. Parents/guardians reported that sunscreen application on children was smooth and even, with the absence of a white cast appearance on children with skin of color. We conclude from this study that this SPF 50 sunscreen is safe to use in ethnically diverse children with a history of AD and sensitive skin. J Drugs Dermatol. 2024;23(8):669-673.  doi:10.36849/JDD.8282.

Validation of the Peak Pruritus-Numerical Rating Scale in patients with chronic plaque psoriasis: results from a phase 2 study.

BACKGROUND: Pruritus is a common, bothersome symptom for patients with mild-to-moderate plaque psoriasis (PsO), yet no validated scale assesses it in this patient population. We aimed to validate the Peak Pruritus-Numerical Rating Scale (PP-NRS) using data from a Phase 2b study investigating the efficacy of brepocitinib in patients with mild-to-moderate chronic PsO. METHODS: Patients completed the PP-NRS daily from baseline for the first 2 weeks after the dose administration and subsequently only on visit days. Test-retest reliability (intraclass correlation coefficient [ICC]), construct validity (known group validity and convergent validity), ability to detect change, and meaningful within-patient change (MWPC) were evaluated using correlation and regression analyses. RESULTS: The PP-NRS demonstrated acceptable test-retest reliability (ICC: 0.86-0.89). Known-group evidence demonstrated that PP-NRS scores could discriminate between different degrees of disease severity. Convergent validity was supported by significant correlation coefficients between the PP-NRS and Patient Global Assessment (PtGA), Dermatology Life Quality Index, and Psoriasis Symptom Inventory, which generally exceeded 0.50. The ability to detect change was evidenced by an approximately linear relationship between changes in PP-NRS and Physician Global Assessment or PtGA of psoriasis scores. The value of 2.8 was determined as the MWPC for the PP-NRS. CONCLUSIONS: PP-NRS is a reliable, practical test for assessing pruritus in mild-to-moderate PsO clinical trials. GOV IDENTIFIER: NCT03850483.

Preference for Cal/BDP Cream or Foam in Patients With Mild to Moderate Plaque Psoriasis.

BACKGROUND: The combined use of topical calcipotriol/betamethasone dipropionate (Cal/BDP) is commonly used and demonstrated to be effective for the management of psoriasis and is shown to confer local anti-inflammatory and immunoregulatory effects. The use of the two agents in combination is synergistic. Despite the demonstrated efficacy of topically applied combination Cal/BDP, successful management of a chronic, relapsing inflammatory skin disease such as psoriasis in the real-world setting may be hindered if patients do not adhere to the dosing or frequency of application recommendations from their prescriber. Patient preference for and satisfaction with the topical treatment vehicle have been shown to influence adherence. A recent analysis has determined that patients perceived Cal/BDP cream vehicle with PAD technology as having favorable characteristics. This randomized, split-body study was undertaken to further assess patient satisfaction with Cal/BDP cream and Cal/BDP foam formulations. TRIAL DESIGN: This was a split-body, subject-blind study. Study cream was administered in a single application to one side of the scalp and/or body; study foam was applied to the contralateral side. Patient self-administered questionnaires were completed before and after product application after a single site visit. RESULTS: Mean overall Vehicle Preference Measure (VPM) scores were higher for Cal/BDP cream than Cal/BDP foam (P=0.0043). Cal/BDP cream also achieved higher individual scores for ease of application, feeling to the touch, smell, and feeling on the skin (P<0.03). With regards to scalp application, subject assessments show that the cream was significantly more preferred in terms of limiting daily disruption (P=0.0008) Conclusion: Results of this study suggest that patients may prefer Cal/BDP cream over Cal/BDP foam for the management of psoriasis on the body and the scalp. Cal/BDP cream outperformed Cal/BDP foam on several specific measures of satisfaction and overall satisfaction measures. J Drugs Dermatol. 2024;23(8):607-611.  doi:10.36849/JDD.7993.

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.

Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis.

INTRODUCTION: A three-pronged approach to acne treatment combining an antibiotic, antimicrobial, and retinoid may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. This study evaluated the efficacy and safety of the first fixed-dose, triple-combination topical acne product, clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) using pooled phase 3 data. METHODS: In two identical phase 3 (N = 183; N = 180), double-blind, 12-week studies, participants aged ≥ 9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily CAB or vehicle gel. Endpoints included ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in acne lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. RESULTS: At week 12, 50.0% of participants achieved treatment success with CAB versus 22.6% with vehicle gel (P < 0.001). CAB resulted in > 70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P < 0.001, both). Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs. Transient increases from baseline in scaling, erythema, itching, burning, and stinging were observed with CAB, but resolved back to or near baseline values by week 12. CONCLUSIONS: The innovative fixed-dose, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear/almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04214639 and NCT04214652.

A Silymarin Antioxidant Serum Improves Facial Acne Alone and as Part of a Treatment Regimen.

BACKGROUND: Silymarin is an antioxidant that can protect against free radicals that cause premature signs of aging and oil oxidation that may contribute to breakouts. AIMS: The objective of these studies was to evaluate a silymarin antioxidant serum alone and in combination with a prescription acne treatment regimen in improving facial appearance in blemish-prone skin.  Methods: Two international studies were conducted. A 12-week study in Brazil enrolled 56 subjects to examine the effect of silymarin antioxidant serum on facial acne. Clinical grading on acne lesions, skin tone, clarity, and postinflammatory hyperpigmentation (PIH) were conducted. In addition, consumer self-assessment, analysis for markers of lipid peroxidation, and sebumeter analysis were completed. Another Unites States (US)/German study enrolled 40 subjects who were on topical prescription acne medications to which silymarin antioxidant serum was added. Acne lesion counts, tolerability, and facial appearance assessments were conducted in this study. RESULTS: The Brazilian study demonstrated a 45% reduction in inflammatory lesions and a 43% reduction in noninflammatory lesions after 12 weeks of silymarin antioxidant serum use. In addition, sebumeter testing showed a 16% reduction in oiliness at week 1. The US/German study showed the benefits of the serum in persons already on prescription acne therapy by reducing facial erythema by 60%, dryness by 49%, and scaling by 67%. CONCLUSION: Silymarin is shown in clinical testing to have significant benefits in reducing lipid peroxidation, oiliness, and PIH, and in improving key markers of skin aging. Additionally, the serum can be used alone or as an adjunctive treatment in acne therapy to further benefit aging, acne-prone skin. J Drugs Dermatol. 2024;23(4):     doi:10.36849/JDD.8120.

Clinical Evaluation of Next-generation, Multi-weight Hyaluronic Acid Plus Antioxidant Complex-based Topical Formulations with Targeted Delivery to Enhance Skin Rejuvenation.

Introduction: Hyaluronic acid (HA) has become a commonly used ingredient in many topical products due to its strong humectant properties and essential role in skin hydration; however, limitations of delivery of HA to only the surface of skin has hindered leveraging the full capacity of HA biology necessary for skin rejuvenation. Here, we describe the clinical efficacy data of a set of novel next-generation, multi-weight HA plus antioxidant complex-based topical formulations with targeted skin delivery to enhance skin rejuvenation. Methods: Four multi-weight HA plus antioxidant complex-based formulations: 1) Multi-Weight HA plus Antioxidant Complex Lotion with SPF 30 (Day Lotion); 2) Multi-Weight HA plus Antioxidant Complex Cream (Night Cream); 3) Multi-Weight HA plus Antioxidant Complex Gel Cream; and 4) Multi-Weight HA plus Antioxidant Complex Boost Serum were clinically evaluated for key attributes including moisturization via corneometer, with clinical grading of: dryness, roughness, fine lines and wrinkles, and following daily use of the individual products for up to eight weeks. Results: Daily use of the multi-weight HA plus antioxidant complex-based formulations demonstrated significant improvements in all parameters evaluated compared to baselines, with changes in moisturization observed within 30 minutes of application, and changes in clinical grading parameters of dryness, roughness, fine lines and wrinkles observed as early as two weeks. Conclusion: These data demonstrate the clinical benefits of daily use of multi-weight HA plus antioxidant complex-based moisturizers for overall improvement in skin health and appearance.

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.

A Multi-center Trial Evaluating a Serum Comprised of Plant-based Adaptogens Targeting Skin Quality.

Objective: The ability of the skin to maintain homeostasis declines with age. Adaptogens support the capacity of the skin to respond to stress. We sought to evaluate the efficacy of a novel serum comprised of plant-based adaptogens for improving photoaged skin following twice-daily application. Methods: A multi-center, 12-week trial was conducted in participants aged 45 to 65 years, Fitzpatrick Skin Type (FST) I to VI, with mild-to-severe photoaging based on a 10-point grading scale (3 [Minimum] to 7 [Maximum]). Visible improvements were assessed in erythema, pore size, skin dullness, skin texture, and uneven pigmentation utilizing a six-point grading scale (0=None to 5=Severe). Global skin quality was measured utilizing our Global Skin Quality Index (GSQI). Sebum measurements were obtained in a subset of participants. Patient satisfaction and tolerability were recorded throughout the study. Results: Fifty-three participants were enrolled and completed the study. Mean age was 56 years and 66 percent were White, 17 percent were Black, 8 percent were Hispanic, 6 percent were Asian/Pacific Islander, and 81 percent had moderate photodamage. At Week 12, significant mean percent improvements from baseline were demonstrated in erythema (50%), dullness (44%), texture (52%), pore size (23%), and uneven pigmentation (21%; all p<.0001). Significant GSQI improvements from baseline were observed at Week 12 (39%; p<0.0001). Significant mean reductions from baseline in skin surface sebum were demonstrated at Week 12 (-38%; p<0.0001). All adverse events (AEs) were mild and transient. Conclusion: A novel serum comprised of plant-based adaptogens, demonstrated improvements from baseline in the appearance of erythema, dullness, texture, pore size, uneven pigmentation, and global skin quality over 12 weeks. Participants reported high levels of satisfaction, with mild, transient AEs reported.

Gene Expression Analysis of a Topical Serum Comprised of Plant-based Adaptogens Developed to Support Homeostasis and Skin Quality.

Objective: A topical serum comprised of plant-based adaptogens was purposefully developed to support the ability of the skin to adapt and achieve balance. The study described herein evaluated changes in the expression of target genes related to skin homeostasis following topical exposure. Methods: Utilizing an in vitro epidermal skin model, quantitative polymerase chain reaction (qPCR) analysis of gene expression was conducted following 48-hour exposure to 15µL of the study product (MYS serum) to the surface of each tissue (N=4). Biomarkers that play a key role in skin homeostasis were analyzed: Aryl hydrocarbon receptor (AhR), chloride channel accessory 2 (CLCA2), metallothionein 1A (MT1A), 1F (MT1F), and 1G (MT1G), and thioredoxin reductase 1 (TXNRD1). Statistically significant changes were calculated using unpaired t-test analysis (p<0.05) versus control (saline). A linear Fold Change (FC) value >2 was considered statistically significant. Results: An 85 percent (FC=1.85) increase in expression of AhR vs. control occurred following exposure to MYS serum indicating enhanced support of cellular and epidermal homeostasis, and the skin barrier's response to stress. Statistically significant increases in expression occurred with TXNRD1 (293%; FC=3.93), MT1A (307%; FC=4.07), MT1F (529%; FC=6.29), and MT1G (163%; FC=12.63) vs. control, indicating support of skin's adaptive response to stress and immune homeostasis. Significantly decreased levels of CLCA2 were demonstrated (69%; FC=-3.24) indicating inhibition of oxidative stress-induced senescence. Conclusion: Utilizing an in vitro epidermal skin model, a serum comprised of plant-based adaptogens demonstrated changes in the expression of target genes that play important roles in skin's ability to respond to stress and achieve homeostasis.

Evaluation of Antioxidants' Ability to Enhance Hyaluronic-acid Based Topical Moisturizers.

Background: Hyaluronic acid (HA) is a unique molecule of the extracellular matrix with multiple biological activities. In skin, HA plays an essential role as a humectant, capable of binding up to 1,000 times its mass with water, providing skin with moisture and viscoelastic properties. HA concentration and synthesis decrease significantly in aging skin, due to exogenous and endogenous factors, including photoaging and HA metabolism. A key driver for HA degradation and reduced concentration is mediated via induction of reactive oxygen species (ROS) and other free radicals. Objective: In this study, we evaluate antioxidant ingredients essential in the development of next-generation HA-based topical formulations aimed at leveraging HA's ability to maximize anti-aging properties. Methods: Two antioxidants, glycine saponin (Glycine soja germ extract) and glycyrrhetinic acid (enoxolone), were evaluated for stimulation of endogenous HA production and inhibition of endogenous hyaluronidase activity, respectively. Results: The antioxidant glycine saponin induced endogenous HA synthesis in fibroblasts, while the antioxidant glycyrrhetinic acid decreased the degradation rate of HA by 54 percent. Conclusion: While HA has been included in numerous topical skin products, critical aspects of HA metabolism, especially in aging skin, have often been overlooked, including decreases in HA synthesis with increasing age, and increases in HA degradation mediated by exogenously induced reactive oxygen species and free radicals and increased enzymatic degradation by endogenous hyaluronidases. Here, we describe a unique approach to inclusion of two antioxidants essential for the development of the next generation of antioxidant complex-based topical skin formulations to limit the signs of aging skin.

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.