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.

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.

Evaluation of a retinol containing topical treatment to improve signs of neck aging.

BACKGROUND: The neck region is an area that can be indicative of signs of skin aging. A novel topical product that combines multiple active ingredients including retinol, tripeptide and glaucine was formulated to specifically target neck aging correction and complement post-procedure as part of an integrated skincare regimen. OBJECTIVES: To evaluate the efficacy of a topical neck treatment through clinical subject evaluation, in addition to ultrasound and biopsy assessment. METHODS: Evaluation for the efficacy of this novel topical product on improving the aging signs of neck skin was performed in multiple clinical trials. The first trial focused on clinical efficacy and included clinical assessment, subject questionnaires, ultrasound imaging and digital photographs. The second trial focused on biomarker analysis through skin biopsy. RESULTS: Data from the clinical trials showed that aging signs on the neck were significantly improved after 12 or 16 weeks of product usage. Changes were readily observed by clinical evaluators and participants. They were documented with digital photos, ultrasound images, and biomarker expression in the skin which clearly display the improvements. CONCLUSIONS: This novel topical product is effective in treating the aging signs on the neck skin and has been shown to provide statistically significant improvement on a myriad of neck aging attributes including fine lines/wrinkles, crepiness, laxity, and texture.

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.

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.

A case study investigating the short-term efficacy and tolerability of a daily serum composed from a unique sunflower sprout extract.

BACKGROUND: Fatigued skin, defined as dehydrated skin with lack of visual facial firmness and dull appearance, can be attributed to intrinsic and extrinsic factors of aging. An anti-aging daily serum (AADS) containing a unique sunflower sprout extract (SSE) was formulated to target fatigued and photodamaged skin. AIMS: Utilizing both preclinical and clinical testing models, the efficacy of the AADS was investigated to improve fatigued and photodamaged skin. PATIENTS/METHOD: Preclinical studies included in vitro analysis of adenosine triphosphate (ATP) production in fatigued dermal fibroblasts, inhibition of ultraviolet radiation A (UVA) induced advanced glycation end products (AGEs) in keratinocytes, and ex vivo gene expression after incubation with the SSE. An institutional review board (IRB)-approved short-term, 7-day, clinical case study was conducted on 28 female subjects, Fitzpatrick skin type I-IV, aged 30-60 years with moderate overall photodamage and skin fatigue. This was a double-blinded, randomized, controlled, single-center case study testing the AADS alone and in combination with an anti-aging facial moisturizer (AAFM). RESULTS: The SSE boosted intracellular ATP production in fatigued fibroblasts and reduced the formation of AGEs in keratinocytes. The SSE increased expression of genes related to epidermal keratinization and downregulated genes related to inflammation. Statistically significant improvement was found after 7 days of twice-daily use of the AADS alone and in combination with the AAFM. Products were well tolerated and perceived by subjects. CONCLUSION: Preclinical results combined with the clinical results strongly suggest that the AADS containing the SSE was tolerable and effective in targeting fatigued and photodamaged skin.

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.

Novel Rotational Combination Regimen of Skin Topicals Improves Facial Photoaging: Efficacy Demonstrated in Double-Blinded Clinical Trials and Laboratory Validation.

Topical antiaging products are often a first-line intervention to counter visible signs of facial photoaging, aiming for sustained cosmetic improvement. However, prolonged application of a single active topical compound was observed clinically to lead to a plateau effect in improving facial photoaging. In view of this, we set out to reduce this effect systematically using a multi-tiered approach with laboratory evidence and clinical trials. The objective of the study was to evaluate the effects of active topical ingredients applied either alone, in combination, or in a rotational manner on modulation of facial photoaging. The study methodology included in vitro, organotypic, and ex vivo skin explants; in vivo biopsy study; as well as clinical trials. We demonstrate for the first time that a pair of known antiaging ingredients applied rotationally, on human dermal fibroblasts, maximized pro-collagen I production. Indeed, rotational treatment with retinol and phytol/glycolic acid (PGA) resulted in better efficacy than application of each active ingredient alone as shown by explants and in vivo biopsy study, with penetration of active ingredients confirmed by Raman spectroscopy. Furthermore, two split-face, randomized, double-blinded clinical trials were conducted, one for 12 months to compare treated vs. untreated and the other for 6 months followed by a 2-month regression to compare treated vs. commercially marketed products. In both studies, rotational regimen showed superior results to its matching comparison as assessed by clinical grading and image analysis of crow's feet wrinkles. In conclusion, rotational regimen using retinol and PGA is effective in treating facial photoaging signs with long-lasting benefits.

A Randomized, Double-Blind, Split-Body, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Tolerability of a Topical Body Firming Moisturizer for Upper Arm Rejuvenation.

BACKGROUND: Aging of upper arm skin, induced by intrinsic and extrinsic factors, often results in a loss of contour, elasticity, and firmness, and an increase in laxity, crepiness, roughness, and photodamage. A topical body firming moisturizer (TBFM) was developed to target all aspects of skin aging. OBJECTIVES: The aim of this study was to evaluate the efficacy and tolerability of the TBFM for upper arm firming and rejuvenation. METHODS: Forty female subjects, 40 to 60 years old, Fitzpatrick skin type II to V, with mild to moderate laxity, crepiness, and photodamage on the upper arms, were recruited into the study, 10 of whom were selected for biopsy analysis. Subjects were randomly allocated to apply the TBFM and placebo moisturizer on the assigned arms twice daily for 12 weeks. At each visit, efficacy and tolerability evaluation, self-assessment, and standardized clinical photography were performed. Ultrasound measurements were performed at baseline, week 8 and week 12. RESULTS: Efficacy evaluation by a clinical grader and bioinstrumentation analysis showed the TBFM improved all skin parameters of the aged upper arm while outperforming the placebo moisturizer after 12 weeks. Clinical photography showed the test product toned and firmed the skin. The TBFM was well tolerated and well perceived by the subjects. Ultrasound images indicated an improvement in skin density and skin structure at week 12. CONCLUSIONS: This clinical trial indicates that the TBFM was well tolerated and was effective in improving crepey, lax, and photodamaged skin of the upper arms after 12 weeks of treatment twice daily.

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.

Evaluation of the Antioxidant Capacity and Protective Effects of a Comprehensive Topical Antioxidant Containing Water-soluble, Enzymatic, and Lipid-soluble Antioxidants.

Objectives: Investigators sought to evaluate the antioxidant capacity of a comprehensive topical antioxidant (WEL-DS), its ability to protect skin against the oxidizing effects of UVA/UVB radiation, and to assess the effectiveness and tolerability of WEL-DS for visible improvements in facial photodamage. Study Designs: In-vitro testing utilized a hydrogen peroxide assay to detect activity in human skin explants following application with WEL-DS, a leading antioxidant serum (L-AOX), and a saline control. Clinical studies included a minimal erythema dose (MED) trial in female subjects, aged 35 to 60 years. Skin was initially irradiated to determine each subject's MED. WEL-DS was applied for four days to one site on the lower back of subjects; the other site remained untreated. Both sites were irradiated with 1X, 2X and 3X each subject's MED, digital images were obtained, and punch biopsies were collected from the 3X MED irradiated areas for histological analysis. A second clinical study evaluated efficacy and tolerability of twice daily application of WEL-DS in female subjects, aged 25 to 65 years with mild-to-moderate photodamage. Changes in fine lines/ wrinkles, dyschromia, erythema, skin tone, pores, and tolerability were assessed at baseline and Weeks 4, 8, and 12. A subset of subjects were evaluated through Week 16. Results: Skin treated with WEL-DS neutralized up to 53 percent more oxidative stress relative to L-AOX. WEL-DS-treated skin demonstrated significantly less UV-induced erythema at 1X, 2X, and 3X MED and demonstrated cellular protective effects versus untreated irradiated skin (N=5). WEL-DS demonstrated average improvements from baseline of 37 percent, fine lines/ wrinkles; 17 percent, skin tone; 13 percent, dyschromia; 18 percent, erythema; and four percent, pores (N=21; Week 12). Continued improvements were demonstrated in all parameters in an extension study (n=14; week 16). WEL-DS was well-tolerated. Conclusion: These studies demonstrate WEL-DS's innate ability to quench free radicals, protect skin from the oxidizing effects of UV radiation, and reduce the visible effects of facial photodamage.

Effective Tyrosinase Inhibition by Thiamidol Results in Significant Improvement of Mild to Moderate Melasma.

Melasma is a pigmentary disorder characterized by hyperpigmented patchy skin in sun-exposed areas, especially the face. Treatment of melasma can be challenging because long-term therapy is required, reoccurrence is common, and existing therapies are insufficient and unsatisfactory. To investigate new treatment options, we performed an exploratory double-blinded, randomized split-face study to assess the efficacy of the tyrosinase inhibitor Thiamidol compared to hydroquinone in women with mild to moderate melasma. After 12 weeks, modified Melasma Area and Severity Index scores significantly improved on both the Thiamidol-treated and the hydroquinone-treated sides of the face. Additionally, Thiamidol treatment improved modified Melasma Area and Severity Index scores significantly better than hydroquinone, and more subjects improved following treatment with Thiamidol (79%) compared with hydroquinone (61%). During treatment, no subjects displayed worsening of modified Melasma Area and Severity Index scores on the Thiamidol-treated side, while approximately 10% of the subjects showed a worsening of modified Melasma Area and Severity Index scores on the hydroquinone-treated side. All subjects routinely used sunscreens and consistent results were obtained in low and in high UV ambient conditions. Subjects rated the efficacy of the Thiamidol formulation significantly better with regard to overall decreased intensity of dark spots and their overall appearance throughout the study. Thiamidol was well-tolerated and well-perceived and represents an effective agent to reduce hyperpigmentation.

A single-center clinical trial to evaluate the efficacy of a tripeptide/hexapeptide antiaging regimen.

INTRODUCTION: An antiaging regimen that aids in clearing the matrix of waste products and stimulating neocollagenesis and neoelastogenesis was tested among a group of subjects over the course of 12 weeks to assess its efficacy in women with mild to moderate wrinkles and skin sagging on the face. MATERIALS AND METHODS: The efficacy of the product regimen was tested in 22 subjects using investigator clinical grading measurements, raking light imaging, 3D imaging, biopsies, and self-assessment questionnaires at baseline and weeks 4, 8, and 12. RESULTS: Clinical grading indicated that use of the antiaging regimen for 12 weeks produced a statistically significant improvement in scores for all evaluated parameters; the raking light image analysis demonstrated a statistically significant improvement in values for length, width, and area of wrinkles when compared with baseline values as did 3D imaging. Biopsy results in the 5 patients tested showed improvement in solar elastosis, collagen stimulation, and improvement in cornified layers in all 5 patients. Elastin stimulation was evident in 3 of 5 patients. Results from the self-assessment questionnaire analysis indicated favorable responses in a statistically significant proportion of subjects after 12 weeks of use for all inquiries. CONCLUSION: Use of this facial antiaging regimen was effective in improving visual facial photoaging conditions and well-perceived when used by women with mild to moderate wrinkles and skin sagging on the face under the conditions of this study.

Efficacy and Tolerability of an Acne Treatment Regimen with Antiaging Benefits in Adult Women: A Pilot Study.

Objective: The objective of this study was to assess clinical safety and efficacy of a novel acne treatment regimen in adult women. Methods: Participants in the study included an ethnically diverse group of adult women (n=24) with mild-to-moderate acne who were treated twice daily with a topical regimen (cleanser, acne cream, and rebalancing gel) for eight weeks. Following baseline assessments, subjects returned to clinic at Weeks 2, 4, and 8 for clinical assessments and self-assessment questionnaires. Results: Twenty-one of the 24 enrolled women completed the eight-week clinical trial. Statistically significant clinical improvements were seen in both acne and aging parameters over time. The product regimen was well tolerated without adverse reactions commonly seen with topical acne products. Conclusion: The regimen demonstrated efficacy and tolerability in adult women with acne and signs of skin aging.

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.

Upregulation of Extracellular Matrix Genes Corroborates Clinical Efcacy of Human Fibroblast-Derived Growth Factors in Skin Rejuvenation.

Skin care products may use various active ingredients to support skin rejuvenation including growth factors and other molecules that help to regenerate extracellular matrix (ECM) and promote skin repair. The biological effect of skin care products with a strong anti-aging claim was assessed in gene expression analyses using an in vitro human skin model. Application of products containing human fibroblast-derived growth factors resulted in signifcant upregulation of genes encoding ECM components including collagens and elastin. Human fibroblasts cultured under hypoxic conditions show increased gene expression of stem cell markers, and their conditioned media could possibly further support skin rejuvenation. Furthermore, a double-blind, randomized, placebo-controlled study was con-ducted in subjects with moderate to severe facial photodamage to assess the cosmetic clinical efficacy of a product containing human fibroblast-derived growth factors. The test product group demonstrated significantly greater reductions in the appearance of fne lines/wrinkles, coarse line/wrinkles, and overall photodamage, compared to the placebo group. Altogether, the results suggest that human fibroblast-derived growth factors support skin rejuvenation by stimulating dermal fibroblasts to generate ECM.

Sun Protection by Beach Umbrella vs Sunscreen With a High Sun Protection Factor: A Randomized Clinical Trial.

Importance: Sun-protective behavior affects skin cancer prevention. Shade works by physically shielding skin from direct harmful UV rays; however, skin may still remain exposed to reflected and indirect UV rays. There is no current standard metric to evaluate shade for its effectiveness in sun protection, and there is insufficient clinical evidence that a beach umbrella alone can provide adequate sun protection. Objective: To directly measure sunburn protection offered by a standard beach umbrella compared with that provided by sunscreen with a high sun protection factor under actual use conditions. Design, Setting, and Participants: A single-center, evaluator-blinded, randomized clinical study was conducted from August 13 to 15, 2014, in Lake Lewisville, Texas (elevation, 159 m above sea level), among 81 participants with Fitzpatrick skin types I (n = 1), II (n = 42), and III (n = 38). Participants were randomly assigned to 2 groups: 1 using only a beach umbrella, and the other using only sunscreen with a sun protection factor of 100. All participants remained at a sunny beach for 3½ hours at midday. Clinical sunburn evaluation of each individual for all exposed body sites was conducted 22 to 24 hours after sun exposure. Interventions: The shade provided by a beach umbrella or protection provided by sunscreen with a sun protection factor of 100. Main Outcomes and Measures: Sunburn on all exposed body sites 22 to 24 hours after sun exposure. Results: Among the 81 participants (25 male and 56 female; mean [SD] age, 41 [16] years) for all body sites evaluated (face, back of neck, upper chest, arms, and legs), the umbrella group showed a statistically significant increase in clinical sunburn scores compared with baseline and had higher postexposure global scores than the sunscreen group (0.75 vs 0.05; P < .001). There was a total of 142 sunburn incidences in the umbrella group vs 17 in the sunscreen group. Thirty-two of the 41 participants (78%) in the umbrella group showed erythema in 1 or more sites vs 10 of the 40 participants (25%) in the sunscreen group (P < .001). Neither umbrella nor sunscreen alone completely prevented sunburn. Conclusions and Relevance: A beach umbrella alone may not provide sufficient protection for extended UV exposure. It is important to educate the public that combining multiple sun protection measures may be needed to achieve optimal protection. Trial Registration: isrctn.org Identifier: ISRCTN19177299.

Ability of sodium copper chlorophyllin complex to repair photoaged skin by stimulation of biomarkers in human extracellular matrix.

PURPOSE: To examine the effect of sodium copper chlorophyllin complex on the expression of biomarkers of photoaged dermal extracellular matrix indicative of skin repair. PATIENTS AND METHODS: Following a previously published 12-day clinical assessment model, skin biopsy samples from the forearms of four healthy females with signs of photoaged skin were obtained and samples were analyzed by immunohistochemistry for key biomarkers of aging skin after each subject was treated with a test material consisting of a gel containing a liposomal dispersion of sodium copper chlorophyllin complex 0.05%, a positive control of tretinoin cream 0.025%, and an untreated negative control. RESULTS: There was a statistically significantly greater amount of fibrillin/amyloid P and epidermal mucins found for skin treated with the test material containing 0.05% sodium copper chlorophyllin complex and the reference control tretinoin 0.025% cream compared to the negative control (untreated site). Expression of procollagen 1 and dermal mucin also showed a greater presence in the samples treated with the test material and the reference control compared to the negative control, though the differences were not statistically significant. No adverse events were observed or reported by the subjects during the course of the study. CONCLUSION: The results of this human biopsy study suggest that both retinoids and sodium copper chlorophyllin complex have beneficial effects on biomarkers of photoaged skin. Products containing both sodium copper chlorophyllin complex and retinols may provide a dual approach to reversing age-related decreases in hyaluronic acid (HA) in the skin: inhibition of the breakdown of HA via sodium copper chlorophyllin complex by inhibition of hyaluronidase, and stimulation of HA synthases by retinol.

An Open Label Clinical Trial to Evaluate the Efficacy and Tolerance of a Retinol and Vitamin C Facial Regimen in Women With Mild-to-Moderate Hyperpigmentation and Photodamaged Facial Skin.

A 12-week open-label, single-center clinical usage trial was conducted to determine the effectiveness of a dual product regimen consisting of a 0.5% retinol treatment and an anti-aging moisturizer with 30% vitamin C in women with mild to moderate hyperpigmented and photodamaged facial skin. Clinical grading of several efficacy parameters, tolerability evaluations, subject self-assessment questionnaires, and digital photography were completed at baseline and at weeks 4, 8, and 12. A total of 44 women completed the study. Effective ingredients incorporated into the 0.5% retinol treatment included encapsulated retinol for a retinol concentration of 0.5%, bakuchiol, and Ophiopogon japonicus root extract. The anti-aging moisturizer with 30% vitamin C contained 30% vitamin C in the form of tetrahexyldecyl ascorbate (THD ascorbate), alpha-tocopheryl acetate (vitamin E) and ubiquinone (coenzyme Q10). The facial regimen produced a statistically significant decrease (improvement) in clinical grading scores for all parameters assessed at weeks 8 and 12 when compared with baseline scores. In addition, the majority of these parameters were improved at week 4. The test regimen was well-perceived by the subjects for various inquiries regarding facial skin condition, product efficacy, and product attributes. Several tolerability parameters were assessed with no statistically significant increase except for dryness. A statistically significant increase in clinical grading scores for dryness on the face occurred at weeks 4 and 8 when compared to baseline scores. The increase in dryness is expected when introducing a retinol product to a facial regimen and the dryness did not persist to the week 12 time point.

Long-term Multi-product Facial Regimen in Subjects with Moderate-to-severe Photodamage and Hyperpigmentation.

BACKGROUND: Photoaged skin is primarily a result of chronic sun exposure. Irregular pigmentation and wrinkling are common clinical manifestations. Monotherapy with retinoids, growth factors, and skin lighteners have proven beneficial. However, long-term treatment with a multi-product facial regimen has not been assessed. OBJECTIVES: This single-center clinical trial was conducted to assess the efficacy and tolerance of a topical multi-product regimen when used by subjects with moderate-to-severe photodamage and hyperpigmentation on the face over a course of 24 weeks. METHODS: Subjects were supplied with a six-product regimen to use on their face (cleanser, growth factor serum, skin brightener, moisturizer, retinol, and sunscreen). Products were used according to specific application instructions. Clinical grading and tolerability assessments were performed at baseline and at follow-up visits at Weeks 4,8,12,18, and 24. Standardized digital photographs were taken and self-assessment questionnaires were conducted. Image analysis for skin-tone evenness and brightness was also conducted. RESULTS: Seventy-two subjects completed the 24-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at all visits. Plateau effects for these improvements were not seen at 24 weeks. The facial regimen was well-tolerated. Subject questionnaires showed the regimen was highly rated at all visits. CONCLUSION: This six-product, comprehensive facial regimen was shown to be clinically effective and well-tolerated for the treatment of moderate-to-severe photodamage and hyperpigmentation over 24 weeks. Additional benefits may occur with continued use.