A randomized, controlled, split-face, double-blind comparison of a multimodality pigment-correcting serum containing lotus sprout extract versus hydroquinone for moderate to severe facial hyperpigmentation, including melasma, in a diverse population.

Background: Hyperpigmentation results in uneven skin tone, with darker skin types disproportionately affected. Objective: Assess efficacy and safety of a novel, hydroquinone (HQ)-free, multimodal pigment-correcting serum (Advanced Brightening Treatment [ABT]) versus 4% HQ in moderate to severe hyperpigmentation, including melasma. Methods: In this split-face study, ABT and 4% HQ were applied topically on randomly assigned facial sides twice daily for 12 weeks. Hyperpigmentation, skin tone evenness, modified Melasma Area and Severity Index (mMASI), Melasma Quality of Life Questionnaire (MelasQoL), self-assessment questionnaires, and tolerability were assessed. Results: Subjects (n = 113; melasma subgroup, n = 44) were Asian (22%), Black/African American (27%), Hispanic (22%), and White/Caucasian (28%). ABT achieved comparable results to 4% HQ. ABT was well tolerated and resulted in improvement versus baseline at all visits in mean overall hyperpigmentation (-11.7% at week 12; P ≤ .001), skin tone evenness (-8.8%, P ≤ .005), and, in the melasma subgroup, mMASI (-50.6%; P ≤ .011) and MelasQoL scores (33.0 vs 46.6 for week 12 vs baseline, respectively; P ≤ .011), with similar results across racial subgroups. ABT was preferred over 4% HQ, with high satisfaction rate (≥89%). Limitations: Quality of life improvements per treatment were not evaluated separately. Conclusion: Efficacy and safety of ABT is comparable to 4% HQ in individuals with facial hyperpigmentation, including melasma, across multiple racial/ethnic backgrounds.

Aesthetic Improvement With Topical Body Skin Treatment as a Complement to Cryolipolysis.

BACKGROUND: A firming and toning cosmetic body lotion (FTB) was developed to target key pathways relevant to body skin health and rejuvenation that may complement the improvements observed after noninvasive body contouring (NIBC). A pilot study explored the efficacy and tolerability of FTB as an adjunct to cryolipolysis. METHODS: An open-label, single-site, single-arm, 12-week study enrolled subjects aged 20 to 65 who had pre-elected to receive 1 or more cryolipolysis treatments (CoolSculpting® or CoolSculpting® Elite; Zeltiq Aesthetics, Inc.) on the inner thigh, back/bra fat, or submental areas. Immediately post-procedure, the investigator applied FTB to the treated area. Subjects then applied FTB topically twice daily for 12 weeks on the treated area. Skin texture and firmness were graded visually by the investigator using a 10-point scale, and subjects graded effectiveness, product attributes, and satisfaction with a questionnaire.  Results: Seventeen subjects (16 women, 1 man) enrolled. After 12 weeks of FTB application, significant improvements in skin firmness were observed in all treated areas, while skin texture showed improvements on the inner thigh and back/bra fat (all P≤0.009). With continued use following cryolipolysis, more than 70% of subjects agreed that FTB improved skin firmness, smoothness, and overall appearance. Subjects indicated that FTB was an effective adjunct to cryolipolysis. Throughout the study, 86% to 92% of subjects reported “fair,” “good,” or “excellent” satisfaction with FTB.  Conclusion: This pilot study suggests that FTB may complement skin improvements seen post-NIBC.J Drugs Dermatol. 2024;23(4): doi:10.36849/JDD.7917.

Efficacy and tolerability of a novel cosmetic growth factor serum when used as part of biweekly diamond tip hydradermabrasion treatments on facial skin.

BACKGROUND: Growth factor preparations have demonstrated effectiveness in reversing age-related changes in facial skin. TNS® Advanced+ Serum (TNS A+ Serum; SkinMedica®, Allergan Aesthetics, an AbbVie Company) and TNS Advanced+ Pro-Infusion Serum for DiamondGlow® (DG-TNS A+; Allergan Aesthetics) combine growth factor technology with active botanical ingredients to target signs of skin aging. AIMS: This prospective clinical study evaluated the effectiveness and tolerability of biweekly facial hydradermabrasion (DiamondGlow [DG]; Allergan Aesthetics) plus DG-TNS A+ combined with at-home topical TNS A+ Serum. METHODS: Females aged 25-65 years with mild to severe facial photodamage received 6 biweekly DG plus DG-TNS A+ in-office treatments with at-home twice-daily TNS A+ Serum for 12 weeks. Investigator-assessed clinical grading of multiple skin attributes, subject self-assessments, instrumentation measurements, and clinical grading of irritation parameters (0-3, none to severe) were conducted at Visit 1, Day 3, and biweekly from Weeks 2-12. RESULTS: Twenty-nine women (Fitzpatrick skin types II-VI; 52% White, 41% African American) were enrolled. Immediate significant improvements after 1 DG plus DG-TNS A+ treatment were observed for fine lines/wrinkles, skin smoothness (visual and tactile), radiance, and hydration (all p ≤ 0.004). From Weeks 6-12, all investigator-assessed parameters showed significant improvements versus baseline (all p ≤ 0.002 at Week 12). Mean tolerability scores were <1 across parameters. All subjects (100%) were satisfied with results at Weeks 2-12. CONCLUSIONS: The combination of biweekly hydradermabrasion plus DG-TNS A+ with at-home TNS A+ Serum treatments was well tolerated and produced immediate, progressive improvement in multiple signs of photoaging in facial skin.

Efficacy and safety of novel topical pigment-correcting regimen with biweekly diamond tip microdermabrasion procedures on facial hyperpigmentation.

BACKGROUND: Facial hyperpigmentation can negatively affect an individual's emotional and psychosocial well-being. AIMS: Assess safety and tolerability of a combination of microdermabrasion (DG) procedures using a novel brightening pro-infusion serum (EC-DG) with a targeted at-home treatment regimen in subjects with mild to severe facial hyperpigmentation, including melasma, post-inflammatory hyperpigmentation, and dark spots. PATIENTS/METHODS: This 12-week, open-label study enrolled 18 subjects (Fitzpatrick skin types I-IV) who underwent 6 in-office DG procedures with EC-DG (one procedure administered biweekly), along with daily topical application of a brightening treatment serum and dark spot cream. End points included change from baseline across multiple skin quality attributes and the Melasma Area and Severity Index (MASI), self-assessment questionnaires, and tolerability assessments. RESULTS: The combination treatment was well tolerated and resulted in significant (p ≤ 0.05) improvements from baseline in radiance, tactile roughness, and moisturization/hydration immediately after the first treatment, in MASI score at day 3, and in overall hyperpigmentation at week 4. Most (94.1%) subjects were satisfied with treatment. CONCLUSIONS: DG procedures using EC-DG combined with a targeted at-home skincare regimen are effective and tolerable for treating facial hyperpigmentation across a broad range of skin types.

Combining Diamond-Tip Dermabrasion Treatments and Topical Skincare in Participants with Dry, Hyperpigmented, Photodamaged or Acne-Prone/Oily Facial Skin: A Clinical Usage Study.

Purpose: An in-office diamond tip microdermabrasion device (DG) was designed to simultaneously exfoliate, extract, and infuse topical cosmetic serums into the skin to improve its appearance. Combining in-office procedures with take-home skincare may enhance treatment outcomes. This study aimed to assess the efficacy of a novel combination of DG treatments with a take-home cosmetic skincare regimen (DGR) to address facial dryness, hyperpigmentation, photodamage, or acne-prone/oily skin. Patients and Methods: In this 12-week, open-label, single-center study, participants were assigned to 1 of 4 groups according to skin presentation: dry, hyperpigmented, photodamaged, or acne-prone/oily. All participants received 6 bi-weekly DG treatments with tailored DGR topical products. During the DG treatment, the dry, hyperpigmented, photodamaged, and acne-prone/oily groups received hydrating, brightening, antioxidant, and pore-clarifying serums, respectively. Study endpoints included investigator grading, standardized photography, and participant questionnaires. Results: Sixteen participants aged 22 to 70 years with Fitzpatrick Skin Types I-V completed the study. Immediately after the first DG treatment, significant improvements in dryness, radiance, texture, photodamage, and fine lines were achieved (P<0.01). At 72 hours, significant improvements were maintained in all these parameters except fine lines (P<0.05). The DG and DGR combination provided significant long-term improvements at week 12 compared to baseline for dryness, radiance, texture, hyperpigmentation, photodamage, skin tone unevenness, and periocular/perioral fine lines (P<0.05). Conclusion: The combination of DG and DGR showed significant immediate and long-term improvements in skin appearance. These results show that the DG and DGR combination is a well-tolerated and effective intervention to enhance different aspects of facial skin quality.

12-Week, Single-Center Study of a Targeted Pigment-Correcting Dark Spot Treatment for Post-Inflammatory Hyperpigmentation and Solar Lentigines.

Purpose: Post-inflammatory hyperpigmentation (PIH) and solar lentigines are dark spots of skin from excessive melanin production due to injury or UV exposure. This 12-week single-center study assessed the efficacy and tolerability of a novel targeted pigment-correcting spot treatment gel suspension cream (Dark Spot Treatment) for improving mild-to-moderate PIH or solar lentigines. Patients and Methods: Female participants (N = 41) aged 25-65 with mild-to-moderate facial dark spots applied Dark Spot Treatment daily for 12 weeks. Investigators assessed overall hyperpigmentation, skin tone evenness, and dark spot intensity, contrast, and size at Weeks 2, 4, 8, and 12. Participant self-assessments occurred at Weeks 1, 2, 4, 8, and 12. Tolerability was assessed by clinical grading and participant reporting. Results: Dark Spot Treatment improved overall hyperpigmentation, skin tone evenness, and dark spot intensity and contrast at Weeks 2 through 12, and dark spot size at Weeks 4 through 12 (all p < 0.001 compared to baseline). Participant self-assessments showed high overall satisfaction. Dark Spot Treatment was well tolerated. Conclusion: The novel pigment-correcting Dark Spot Treatment significantly improved the appearance of PIH and solar lentigines, had high participant satisfaction, and was well tolerated.

Restoration of Aging Body Skin: Evidence-Based Development of a Topical Formulation for Improving Body Skin Quality.

BACKGROUND: Age-related changes in body skin are emerging as important therapeutic targets. A novel topical firming and toning body lotion (FTB) has been developed to target multiple pathways involved in body skin rejuvenation. METHODS: FTB was evaluated in a randomized, double-blind, vehicle-controlled, 12-week study in women (N=54) with mild to moderate lack of firmness on the upper arms and mild to moderate cellulite on the thighs. Investigator clinical assessments, instrumentation evaluations, and patient questionnaires were performed. Histological assessment of ex vivo human skin treated with FTB and gene expression analysis in 3-dimensional human skin models following application of FTB or product comparators were conducted. RESULTS: At week 12, FTB treatment significantly improved (vs baseline) firmness, sagging, smoothness, texture, cellulite, and crepiness on investigator-, instrument-, and photographically assessed outcomes. Participants reported significant improvements in self-perceived efficacy and overall satisfaction with the appearance of their skin following FTB treatment vs vehicle control. Adverse events were mild or moderate in severity. FTB supported new collagen and elastic fiber formation in ex vivo skin. FTB increased skin rejuvenation–associated gene expression vs comparator products. CONCLUSIONS: FTB provided significant improvements in the upper arms and thighs compared with baseline and vehicle control across multiple investigator and instrumentation evaluations. Most participants reported greater efficacy and treatment satisfaction with FTB vs vehicle. FTB treatment stimulated dermal extracellular matrix renewal and induced expression of genes involved in skin rejuvenation pathways. This study provides clinical and preclinical evidence supporting the use of FTB to improve body skin quality. Citation: Makino ET, Jiang LI, Acevedo SF, et al. Restoration of aging body skin: evidence-based development of a topical formulation for improving body skin quality. J Drugs Dermatol. 2023;22(9):887-897. doi:10.36849/JDD.7292.

Efficacy and Tolerability of Cosmetic Serums Enriched with Five Forms of Hyaluronic Acid as Part of Biweekly Diamond Tip Microdermabrasion Treatments for Facial Skin Dryness and Age-Associated Features.

Purpose: There is growing interest in combining topical treatments with aesthetic procedures to combat signs of aging skin. This study aimed to assess the efficacy and tolerability of a novel cosmetic serum containing 5 different forms of HA (HA5 DG) when used via a proprietary diamond-tip microdermabrasion procedure (DG) to treat skin dryness, fine lines/wrinkles, rough texture, and dullness. Patients and Methods: In this open-label, single-center study, participants received HA5 DG as part of a biweekly DG procedure on the face and neck for 12 weeks. Study participants also applied another take-home HA5 serum to the face twice daily at home, along with a basic skincare regimen. The efficacy of the combined treatment was measured by clinical quantification of multiple skin appearance features, analysis of bioinstrumental measurements, and digital photography. Results: This study enrolled 27 participants, with an average age of 42.7 years and Fitzpatrick skin phototypes I-III (59.3%), IV (18.5%), and V-VI (22.2%), and 23 participants completed the study. The combined treatment had effects in fine lines/wrinkles, skin dryness, smoothness, radiance, firmness, and hydration 15 minutes post-DG. Furthermore, the significant improvements observed in dryness, fine lines/wrinkles, skin smoothness, and radiance were still visible 3 days after and maintained at week 12. Additionally, smoothing of coarse lines/wrinkles, improvement of skin tone evenness, hyperpigmentation, photodamage, and transepidermal water loss were observed at week 12. The treatment had a favorable tolerability profile and was perceived as efficacious and highly satisfactory. Conclusion: This novel combined treatment delivered immediate and prolonged skin hydration and high participant satisfaction, proving it can be an excellent approach for skin rejuvenation.

Effects of a Topical Growth Factor Regimen Following Pre-elected Cosmetic Facial Injection Procedures.

BACKGROUND: There are limited studies evaluating topical cosmetic skincare products following cosmetic facial injections. OBJECTIVE: An open-label study assessed a novel medical-grade topical skincare regimen following cosmetic facial injections. METHODS: The study enrolled 20 women with moderate to severe facial photodamage who used non–physician-dispensed skincare products and pre-elected to receive facial neuromodulator and hyaluronic acid (HA) dermal filler injections. All subjects continued regular skincare through week 4 after facial injection, then switched to the novel regimen (growth factor product, TNS Advanced+; day/night antioxidant serum system, Lumivive; HA-based hydrator, HA5; and basic skincare components) through week 16. RESULTS: At week 4, significant (P≤0.05) improvements from baseline were seen for multiple investigator-graded skin quality parameters, including overall photodamage, tactile roughness, and skin tone evenness, as well as fine and coarse lines/wrinkles. After switching to the novel regimen, additional significant improvements in overall skin quality and forehead, cheek, and perioral fine lines/wrinkles were observed at week 8 (all P≤0.05 vs week 4), which continued through week 16. CONCLUSION: This study highlights the importance of topical skincare in conjunction with cosmetic facial injections to holistically optimize overall skin quality and appearance. J Drugs Dermatol. 2023;21(1): doi:10.36849/JDD.7160.

Protective effects of a day/night dual-antioxidant serum on skin: A randomized, regimen-controlled study in Chinese women exposed to air pollution.

BACKGROUND: Chronic exposure to air pollution can negatively affect skin health. AIMS: To assess the efficacy of the LUMIVIVE® System (LVS), a skincare system consisting of individual day and night serums, in Chinese women exposed to air pollution. PATIENTS/METHODS: In this single-center, vehicle-controlled study, eligible females (mean age, 49.02 years) were randomized 1:1 to treatment group (LVS plus basic moisturizer) or control group (basic moisturizer). Skin color, sebum content, barrier function, elasticity, and texture were measured at baseline and at each follow-up visit (days 28, 56, and 84). Air pollution parameters were collected throughout the study. RESULTS: Air pollution levels, including PM2.5 and NO2 , were consistently high during the study. The treatment group showed significantly higher skin color L* (p ≤ 0.0001) and lower a* values (p ≤ 0.05) at all follow-up visits compared with the control group, indicating lower skin pigmentation and redness, respectively. Skin color L* and a* values remained unchanged over time for the control group but were significantly different at all follow-up visits compared to baseline (p ≤ 0.0001 and p ≤ 0.05, respectively) for the treatment group. There was an increasing trend for sebum content in the control group, which was not observed in the treatment group. Both groups showed improvements over time in other skin physiology parameters. CONCLUSIONS: The current analysis demonstrates the efficacy of LVS plus basic moisturizer compared with basic moisturizer alone to reduce skin pigmentation and redness, as well as to mitigate sebum production, in Chinese women exposed to air pollution.

Targeting Multiple Hallmarks of Skin Aging: Preclinical and Clinical Efficacy of a Novel Growth Factor-Based Skin Care Serum.

INTRODUCTION: The aging process involves numerous biological mechanisms that have been characterized and proposed as the "hallmarks of aging." Targeting the processes and pathways related to these hallmarks of aging that cause and promote skin aging could provide anti-aging benefits. A novel topical growth factor-based skin care serum (A+) was developed using human fibroblast conditioned media. This study aimed to assess the effects of A+ on four hallmarks of aging and its clinical efficacy in skin rejuvenation in subjects with moderate to severe overall facial photodamage. METHODS: Preclinical studies included immunohistochemistry in human ex vivo skin, and gene expression analysis in human 3D skin models. A 24-week, vehicle placebo-controlled study, including FaceQ patient-reported outcomes and skin biopsy analysis, was performed to assess clinical efficacy and tolerability. RESULTS: Treatment with A+ resulted in reduced expression of cell senescence biomarker H2A.J and upregulation of genes associated with proteasome, autophagy, stemness, and intercellular communication. Clinical assessments showed A+ provided significantly greater reductions in sagging, coarse lines/wrinkles, fine lines/wrinkles, overall photodamage, and overall hyperpigmentation compared with placebo. Subjects felt they appeared younger-looking, reporting a median decrease in self-perceived age of 6 years after 12 weeks of use. Decreased levels of H2A.J and increased expression of key dermal extracellular matrix and epidermal barrier components, including collagen and elastin, were observed in skin biopsy samples. CONCLUSION: The present study shows for the first time the potential effects of a topical growth factor-based cosmeceutical on cellular processes related to four hallmarks of aging (cellular senescence, loss of proteostasis, stem cell exhaustion, and altered intercellular communication) to help delay the aging process and restore aged skin. A+ targets the biological mechanisms underlying the aging process itself and stimulates skin regeneration, resulting in rapid and significant clinical improvements.

Improvements in skin quality parameters in postmenopausal participants after use of topical growth factor serum.

BACKGROUND: Photodamage can induce skin aging processes that can be particularly concerning for postmenopausal women. Growth factors from hypoxic human fibroblast-conditioned media have demonstrated improvements in skin quality parameters. AIMS: The aim of the study was to assess efficacy and tolerability of topical combination-treatment hypoxic growth factor serum (TNS A+) in postmenopausal women with moderate to severe facial photodamage. PATIENTS/METHODS: In this 12-week, open-label, single-center study, participants used TNS A+ serum twice daily. Postmenopausal women (40-65 years of age) with Fitzpatrick skin types I-VI and modified Griffiths scale scores 4-9 were eligible. Clinical and participant-reported assessments were evaluated at Weeks 6 and 12. Statistical significance was defined as p ≤ 0.05. RESULTS: There were 17 enrolled participants. TNS A+ treatment demonstrated significant improvements from baseline in fine lines and wrinkles in periocular, forehead, and cheek areas at Week 12 and the perioral area at Weeks 6 and 12. Significant improvements from baseline in coarse lines and wrinkles were observed for the perioral area at Week 12 and periocular and cheek areas at Weeks 6 and 12. Improvements in overall photodamage, skin tone evenness, and tactile roughness were significantly greater at Weeks 6 and 12 versus baseline. Most participants reported TNS A+ made their skin look and feel smooth, soft, and rejuvenated; improved skin radiance; made lines and wrinkles less apparent; and improved skin texture. No treatment-related adverse events were reported. CONCLUSIONS: The TNS A+ regimen was well tolerated and provided significant improvements in skin quality in postmenopausal women with moderate to severe facial photodamage.

Assessing changes in facial skin quality using noninvasive in vivo clinical skin imaging techniques after use of a topical retinoid product in subjects with moderate-to-severe photodamage.

BACKGROUND: Studies utilizing reflectance confocal microscopy (RCM) and dynamic optical coherence tomography (D-OCT) to assess cosmetic skin changes are limited. METHODS: A 12-week, open-label study was conducted using RCM and D-OCT to evaluate the effects of a topical cosmetic retinol (RET05) on subjects with facial photodamage. Study endpoints included investigator grading, standardized (VISIA-CR) and 3D photography (Antera 3D), independent RCM (VivaScope1500) and D-OCT (VivoSight) image analysis, validated FACE-Q scales, and subject questionnaires. RESULTS: Twenty-three subjects, 45- to 68-year old, with Fitzpatrick skin types II-IV completed the study. After 12 weeks of repeated application, RET05 demonstrated significant corresponding cosmetic improvements for overall photodamage, skin tone unevenness, tactile roughness, fine lines/wrinkles (forehead, periocular, and perioral), and coarse lines/wrinkles (forehead, periocular, and cheeks), and Allergan Skin Roughness Scale. FACE-Q assessments also demonstrated significant improvements from baseline at week 12. RCM analysis showed decreases in all epidermis, less compact stratum corneum (SC), more non-compact SC, decreases in coarse/huddled dermal fibers, and increases in fibrillar dermal fibers, as compared to baseline. D-OCT analysis showed significant decreases in epidermal thickness (ET), reduction of moderate/many collagen fragments and collagen bundles, and significant increases in the stroma attenuation coefficient and collagen density. Moreover, the dermal-epidermal junction was more pronounced, and vascular abundance at 300 and 500 µm depth increased. Independent evaluation of RCM and D-OCT images showed similar decreases in ET and improvements in dermal fibers. CONCLUSION: This study was the first to utilize RCM and D-OCT to evaluate the cosmetic effects of a topical retinoid and further substantiate improvements in skin quality.

Pigmentation control in pregnancy-induced melasma: Clinical assessment of a non-hydroquinone, non-retinol pigment-correcting serum.

BACKGROUND: Melasma is an acquired disorder that results in irregular brown patches on the skin that can occur due to hormonal changes. Although pregnancy-induced melasma is usually temporary, it can become a chronic condition, with significant negative impact on quality of life (QoL). AIMS: Determine the efficacy and tolerability of a topical, non-hydroquinone, non-retinol pigment-correcting serum (LYT2) for the treatment of pregnancy-induced melasma. METHODS: This 12-week, single-center clinical trial enrolled 34 non-pregnant women who developed mild to severe facial melasma following a previous pregnancy (mean age, 42 years). LYT2 was applied twice daily to facial skin for 12 weeks in addition to a basic skincare regimen. Outcomes included changes from baseline in skin physiology parameters, such as brightness (L*), using objective digital image analysis, investigator-rated Overall Hyperpigmentation scale, Global Improvement, and Melasma Area and Severity Index (MASI), as well as subject-assessed Melasma Quality of Life Scale. Subjects also completed a questionnaire on self-perceived efficacy and attributes of the study product. Tolerability was assessed by the investigators (erythema, scaling, and edema) and subjects (burning/stinging and itching). Clinical assessments were conducted at baseline and Weeks 4, 8, and 12. RESULTS: LYT2 provided statistically significant reductions in overall hyperpigmentation scores as early as Week 4 (-5.8% change from baseline) and continued through Week 12 (-14.6% change from baseline; all p < 0.001). Significant improvements in MASI scores and QoL were also achieved following LYT2 treatment, which was well tolerated. CONCLUSIONS: LYT2 represents a new efficacious alternative to hydroquinone-based treatments for pregnancy-induced melasma.

Assessment of Circadian-based Antioxidants Plus a Comprehensive Brightener in Skin of Color Patients With Hyperpigmentation.

BACKGROUND: Hyperpigmentation disorders disproportionately affect individuals with skin of color. There is an unmet need for safe and effective topical treatments for this population. OBJECTIVE: The efficacy and tolerability of LYT2 in combination with LVS were assessed in skin of color patients with moderate to severe facial hyperpigmentation. METHODS: A single-arm study was performed in Asian, Hispanic, or African American patients (Fitzpatrick phototypes III–VI). Subjects applied LYT2 and LVS daily, in addition to a basic skincare regimen, for 12 weeks. Overall hyperpigmentation, skin-tone evenness, and radiance were evaluated by the investigator, and subjects completed questionnaires regarding self-perceived efficacy. RESULTS: After 12 weeks, the combination of LYT2 and LVS produced a 23% improvement in overall hyperpigmentation, a 33% increase in skin-tone evenness, and a 51% increase in radiance compared to baseline. At the study conclusion, all patients noted at least a slight improvement in skin condition, and 70% reported good or excellent satisfaction. One subject (8%) experienced a treatment-related adverse event. CONCLUSION: The combination of LYT2 and LVS was well-tolerated and improved the appearance of hyperpigmentation and overall quality in skin of color. J Drugs Dermatol. 2022;21(4):376-380. doi:10.36849/JDD.6687.

Clinical assessment of a circadian-based antioxidant system combined with a comprehensive brightening serum in diverse subjects with moderate-to-severe facial hyperpigmentation.

BACKGROUND: Hyperpigmentation conditions can affect all skin types but occur more frequently in darker skin. Because many factors have been implicated in the etiologies of these disorders, multi-targeted approaches may be required to achieve a better overall outcome in a diverse patient population. AIMS: The purpose of this study was to investigate the safety and efficacy of a combination regimen of a comprehensive cosmetic brightening agent (LYT2) with a broad blend of antioxidants (LVS) to reduce hyperpigmentation and improve overall skin appearance. METHODS: The combination of LYT2 and LVS, in addition to a basic skincare routine, was evaluated in subjects of either Caucasian or Asian (a majority of whom were Indian) descent, presenting with moderate-to-severe hyperpigmentation. Efficacy evaluations consisted of investigator clinical grading of overall hyperpigmentation, skin tone evenness, and radiance, as well as subject self-assessment questionnaires. RESULTS: Immediate and progressive improvement was noted by the investigators for all assessed parameters. At the end of the 12-week study, investigators observed a 45% mean decrease from baseline for overall hyperpigmentation. In addition, a 50% improvement in skin tone evenness and a 58% increase in radiance was observed. These investigator assessments were matched by good patient scores for self-perceived efficacy parameters and high overall satisfaction. One patient (7%) showed a treatment-related adverse event. CONCLUSION: A combination skincare regimen that combines the pigmentation control of LYT2 with the broad antioxidant defense of LVS is a well-tolerated and effective treatment option to improve the appearance of facial hyperpigmentation and make skin more radiant.

Efficacy and Tolerability of a Novel Topical Treatment for Neck: A Randomized, Double-blind, Regimen-Controlled Study.

The neck plays a telling role as an age indicator. Due to its anatomy and function, neck skin ages differently than facial skin and special considerations need to be taken when providing treatment. A randomized, double-blind, regimen-controlled study was conducted to assess the efficacy and tolerability of a novel topical cosmetic cream (NCC) specifically tailored to address the signs of skin aging of the neck and décolletage. Twice daily application of NCC significantly improved skin sagging/laxity of the neck as well as the appearance of fine and coarse lines/wrinkles, crepiness, tactile roughness, overall skin texture, hyperpigmentation, skin tone evenness, and radiance. NCC also significantly improved the appearance of fine and coarse lines/wrinkles, tactile roughness, hyperpigmentation, skin tone evenness, and radiance of the décolletage. Investigator assessments were corroborated by objective cutometer measurements that demonstrated improved skin firmness and elasticity. In vitro analysis in human 3D skin models show that stimulation of neocollagenesis and neoelastogenesis as well as support of cellular proteostasis through proteasome and autophagy activation are potential mechanisms of action for the observed clinical outcomes. J Drugs Dermatol. 2021;20(2):184-191. doi:10.36849/JDD.5819 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

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.

Clinical Efficacy of a Novel Two-Part Skincare System on Pollution-Induced Skin Damage.

INTRODUCTION: Air pollution continues to be a global health concern and recent studies have shown that air pollutants can cause skin damage and skin aging through several pathways that induce oxidative stress, inflammation, apoptosis, and skin barrier dysfunction. Preventive measures need to be considered to retain optimal skin health, and topical skincare products may be able to alleviate the negative effects of air pollution on skin. A randomized, double-blind, placebo-controlled clinical usage study was conducted to assess the efficacy and tolerability of a novel two-part skincare system (LVS) that was developed to provide protection against environmental skin aggressors including air pollution. After 8 weeks of use in subjects exposed to extremely high levels of pollution, LVS provided significant improvements compared to placebo in all clinical efficacy parameters including crow's feet wrinkles, overall skin damage, skin tone evenness, tactile roughness, and visible redness. Subject self-assessment questionnaires showed that the treatment product was highly rated in self-perceived efficacy. Decreased SQOOH and MDA content in skin swab samples suggest that LVS helped to reduce oxidative stress in patients' skin. Histological analyses of biopsy samples using biomarkers related to skin structure, damage and function (collagen IV, MMP1, CPD, and CD1a) further support the clinical benefits of LVS. Altogether, the presented study is among the first to show that topical skincare products can help to reduce pollution-induced skin damage and improve skin quality, especially when specifically formulated with active ingredients that combat the harmful effects of air pollutants. J Drugs Dermatol. 2018;17(9):975-981.

Addressing Male Facial Skin Concerns: Clinical Efficacy of a Topical Skincare Treatment Product for Men.

The growing male skincare market reflects the increased interest of men in addressing facial aging concerns and maintaining a healthy youthful appearance. Because of differences in skin structure and aging as well as in lifestyle and behavior, male facial skin presents unique challenges that may result in different priorities or treatment strategies compared to female skin. A clinical study was conducted to assess clinical efficacy and tolerability of a topical skincare treatment product that was developed to address several male facial skin concerns related to skin quality, skin aging, and shaving. The treatment product provided significant improvements in all clinical efficacy parameters including overall photodamage, tactile roughness, fine line/wrinkles, and coarse lines/wrinkles. Furthermore, significant improvements in erythema as well as dryness/scaling were observed. Subject self-assessment questionnaires showed that the treatment product was highly rated in both self-perceived efficacy as well as product attributes. Use of skincare treatment products that tackle specific male facial skin concerns could further optimize skin quality and support healthy and youthful looking skin in men.

J Drugs Dermatol. 2018;17(3):301-306.