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.

A Prospective Six-month Single-blind Study Evaluating Changes in Hair Growth and Quality Using a Nutraceutical Supplement in Men and Women of Diverse Ethnicities.

Objective: The goal of this study was to assess the perceived efficacy of a standardized nutraceutical to improve hair growth and quality in men and women of various ethnicities with self-perceived hair thinning. Methods: This prospective, single-blind study enrolled healthy men aged 20 to 55 years (n=47) and premenopausal women aged 20 to 45 years (n=51) with self-perceived, mild-to-moderate hair thinning and included African American, Asian, Hispanic Caucasian and Non-Hispanic Caucasian participants. The nutraceutical supplement (Nutrafol® Men or Women Capsules, Nutraceutical Wellness Inc., New York, New York) was taken daily for six months. Subjects were evaluated in the clinic at baseline and Weeks 12 and 24 with two self-assessments at Weeks 4 and 8. Study endpoints were standardized digital imaging and investigator rated assessments. Self-assessment questionnaires rated hair growth, hair satisfaction, and lifestyle factors. Results: Investigator ratings for baseline hair growth, coverage, density, and volume were significant at Weeks 12 and 24 for all subjects (for each, p<0.001). These significant improvements were seen in 83.7 percent of men and 79.5 percent of women at Week 24. Results were similar across ethnic subgroups with significant benefit at Weeks 12 and 24 (for each, p<0.05). All subjects reported significant improvements in baseline hair appearance/quality, volume/fullness, scalp coverage, thickness, and shedding at Weeks 4, 8, 12 and 24 (for each, p<0.01). Conclusion: A standardized nutraceutical supplement improved visible hair growth with less notable shedding based on subjects' and investigators' overall perception of treatment benefit for men and women of various ethnic backgrounds.

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.

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.

Split-face Evaluation of a Multi-ingredient Brightening Foam Versus a Reference Control in Women with Photodamaged Facial Skin.

Background: The gold standard for the treatment of hyperpigmentation is hydroquinone (HQ), which has been available as a skin lightener for more than 50 years. Numerous clinical studies have proven its efficacy in various topical formulations. In the United States, HQ is available as a nonprescription product in 2% formulations and as a 4% prescription product. Objective: This study compared the safety and efficacy of a 2% hydroquinone multi-ingredient foam with a standard 4% hydroquinone cream on photodamaged facial skin. Methods: A 12-week, investigator-blinded, randomized trial with a split-face design was conducted in women with moderate photodamaged facial skin. Results: Both products improved the appearance of photodamaged facial skin and were well-tolerated. No statistically significant changes were seen between treatments during the efficacy or tolerability evaluations. Conclusion: Both treatments (2% HQ Brighten and 4% HQ) improved the appearance of photodamaged facial skin and were well-tolerated and results well-perceived by subjects over the 12-week treatment period, compared with baseline grading scores.

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.

Efficacy of Trifecting® Night Cream, a Novel Triple acting Skin Brightening Product: A Double-blind, Placebo-controlled Clinical Study.

Background: Melasma is a common, persistent disorder of hyperpigmented facial skin predominantly attributed to ultraviolet light exposure, hormonal influences, and genetic predisposition. Objectives: This double-blind, placebo-controlled, randomized clinical trial was conducted to assess the efficacy and tolerance of a multimodality night cream when used over a course of 24 weeks followed by a four-week regression in female subjects with moderate to severe melasma, presence of solar lentigines, and periocular lines and wrinkles. Methods: Subjects were randomized into one of two groups: Cell 1 received Trifecting® Night Cream (Envy Medical, Long Beach, California) 1.0 and Cell 2 did not. All subjects were supplied with a two-product regimen comprising a cleanser and sunscreen to use during the trial. Clinical grading, tolerability assessments, and Chroma Meter measurements (Konica Minolta, Tokyo, Japan) were performed at baseline and at Weeks 8, 16, 24, and 28 (regression). Standardized digital photographs were taken and self-assessment questionnaires were completed. Results: Twenty-five subjects completed the 28-week study, with 14 subjects in Cell 1 and 11 subjects in Cell 2. Subjects in both groups showed improvements in facial conditions. Cell 1 outperformed Cell 2 in improving fine lines, solar lentigines, and melasma conditions. These improvements were sustained during regression period. Conclusions: Trifecting® Night Cream 1.0, is effective for the treatment of moderate to severe melasma, solar lentigines, and periocular lines and wrinkles over 24 weeks of usage, with its benefits sustained for at least four weeks after treatment.

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.

A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating an Oral Anti-aging Skin Care Supplement for Treating Photodamaged Skin.

OBJECTIVE: Evaluate an anti-aging skin care supplement on the appearance of photodamaged skin. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. Following a one-month washout period, subjects received two anti-aging skin care formula tablets (total daily dose: marine complex 210mg, vitamin C 54mg, zinc 4mg) or placebo daily for 16 weeks. Subjects were restricted from products/procedures that may affect the condition/appearance of skin, including direct facial sun or tanning bed exposure. PARTICIPANTS utilized a standardized facial cleanser and SPF15 moisturizer. SETTING: Single study center (Texas, United States; June-November 2007). PARTICIPANTS: Healthy women aged 35 to 60 years (mean, 50 years), Fitzpatrick skin type I-IV, modified Glogau type II-III. MEASUREMENTS: Subjects were assessed at Weeks 6, 12, and 16 on clinical grading (0-10 VAS), bioinstrumentation, digital photography, and self-assessments. Analysis of variance with treatment in the model was used for between-group comparisons (alpha P≤0.05). RESULTS: Eighty-two anti-aging skin care formula subjects and 70 placebo subjects completed the study. Significant differences in change from baseline to Week 16 scores were observed for clinical grading of overall facial appearance (0.26; P<0.0001), radiant complexion (0.59; P<0.0001), periocular wrinkles (0.08; P<0.05), visual (0.56; P<0.0001) and tactile (0.48; P<0.0001) roughness, and mottled hyperpigmentation (0.15; P<0.001) favoring the subjects in the anti-aging skin care supplement group. Ultrasound skin density (Week 16) was significantly reduced for placebo versus anti-aging skin care supplement group (-1.4% vs. 0%; P<0.01). Other outcomes were not significant. Mild gastrointestinal symptoms possibly related to the anti-aging skin care supplement (n=1) and placebo (n=2) were observed. CONCLUSION: Women with photodamaged skin receiving anti-aging skin care supplement showed significant improvements in the appearance of facial photodamage. TRIAL REGISTRY: Not applicable. Study precedes FDAAA 801 clinical trial registration and results submission requirements.

A placebo-controlled, double-blind clinical trial to evaluate the efficacy of Imedeen(®) Time Perfection(®) for improving the appearance of photodamaged skin.

OBJECTIVE: To assess the efficacy of Imedeen Time Perfection for improving the appearance and condition of photoaged skin in healthy women. METHODS: This randomized, double-blind, placebo-controlled clinical trial enrolled healthy women, 35-60 years of age, with Fitzpatrick I-III and Glogau II-III skin types and mild-to-moderate facial fine lines/wrinkles. The eligible subjects were randomized to receive two tablets daily of either Imedeen Time Perfection (Imedeen) or a matching placebo for 12 weeks. Efficacy assessments included investigator rating of 16 photoaging parameters (ie, global facial appearance and 15 individual facial parameters and the average of all parameters), instrumentation (ie, ultrasound dermal density, moisture level of the stratum corneum, transepidermal water loss, cutometry), and subjects' self-assessment. Differences in the mean change from baseline to week 12 values on these outcomes were compared between Imedeen and placebo using analysis of variance or a paired t-test. RESULTS: Seventy-four subjects with primarily Fitzpatrick skin type III (78%-79%) and Glogau type III (53%-58%) completed the study (Imedeen: n=36; placebo: n=38). The mean difference in change from baseline to week 12 for global facial assessment significantly favored Imedeen over placebo (-0.52; P=0.0017). Additionally, the mean differences in the average of all facial photoaging parameters (-0.29), mottled hyperpigmentation (-0.25), tactile laxity (-0.24), dullness (-0.47), and tactile roughness (-0.62) significantly favored Imedeen over placebo (P≤0.05). Significantly greater increases in ultrasound dermal density (+11% vs +1%; P≤0.05) and stratum corneum moisturization (+30% vs +6%; P≤0.05) were also observed for Imedeen than for placebo. There were no significant differences on other instrumental outcomes. CONCLUSION: The results of this study suggest that Imedeen Time Perfection can positively affect the appearance of photoaged skin, moisturization, and skin density over 12 weeks of treatment.

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.

Pilot Study of Topical Copper Chlorophyllin Complex in Subjects With Facial Acne and Large Pores.

BACKGROUND: Acne vulgaris is one of the most common skin diseases treated by dermatologists. Salts of copper chlorophyllin complex are semi-synthetic naturally-derived compounds with antioxidant, anti-inflammatory and wound healing activity that have not been previously tested topically in the treatment of acne-prone skin with enlarged pores. OBJECTIVES: This single-center pilot study was conducted to assess the efficacy and safety of a liposomal dispersion of topically applied sodium copper chlorophyllin complex in subjects with mild-moderate acne and large, visible pores over a course of 3 weeks. METHODS: Subjects were supplied with the test product, a topical gel containing a liposomal dispersion of sodium copper chlorophyllin complex (0.1%) with directions to apply a small amount to the facial area twice daily. Clinical assessments were performed at screening/baseline and at week 3. VISIA readings were taken and self-assessment questionnaires were conducted. RESULTS: 10 subjects were enrolled and completed the 3-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at week 3. The study product was well tolerated. Subject questionnaires showed the test product was highly rated. CONCLUSIONS: In this pilot study, a topical formulation containing a liposomal dispersion of sodium copper chlorophyllin complex was shown to be clinically effective and well tolerated for the treatment of mild-moderate acne and large, visible pores when used for 3 weeks.

Assessment of the safety and efficacy of topical copper chlorophyllin in women with photodamaged facial skin.

BACKGROUND: Chronic exposure to the sun causes the skin to prematurely age. Photodamaged skin is characterized by progressive damage to the dermal extracellular matrix with loss of collagen and degradation of elastin. Clinical manifestations of such photoaged or photodamaged skin include wrinkles and irregular pigmentation. Various cosmetic treatments including topical retinoids, growth factors, and skin lighteners have shown some benefit. Salts of copper chlorophyllin complex are semi-synthetic naturally derived compounds with anti-oxidant and wound healing activity that has not been previously tested in photodamaged skin. OBJECTIVES: This single-center pilot study was conducted to assess the efficacy and safety of a liposomal dispersion of topically applied sodium copper chlorophyllin complex in women with mild-moderate fine lines and wrinkles in the periocular areas and facial solar lentigenes over a course of 8 weeks. METHODS: Subjects were supplied with the test product, a topical gel containing chlorophyllin complex salts (0.066%), with directions to apply a pea-sized amount to the periocular areas, cheeks and nose every morning and evening. Clinical assessments were performed at screening/baseline and at week 8. Standardized digital photographs were taken and self-assessment questionnaires were conducted. RESULTS: Ten subjects completed the 8-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at week 8. The study product was well tolerated. Subject questionnaires showed the test product was highly rated. CONCLUSIONS: In this pilot study, a topical formulation containing a liposomal dispersion of sodium copper chlorophyllin complex was shown to be clinically effective and well tolerated for the treatment of mild-moderate photodamage and solar lentigenes when used for 8 weeks.

Efficacy and Tolerability of Steroid-Free, Over-the-Counter Treatment Formulations in Infants and Children With Atopic Dermatitis.

BACKGROUND: Two steroid-free, over-the-counter skin protectant products have been developed for the care and treatment of atopic dermatitis (AD)-Eucerin Eczema Relief Body Crème (Body Cream) for daily skin moisturization and Eucerin Eczema Relief Instant Therapy cream (Instant Therapy) for treatment of AD flare-ups. We tested the efficacy and tolerability of these formulations in infants and children with AD. METHODS: Study 1: Body Cream was applied twice daily to the lower legs of 64 children with a history of AD (aged 3 months to 12 years) for 14 days. Study 2: Instant Therapy was applied to active lesions and surrounding skin of 29 children (aged 3 months to 12 years) with active atopic lesions. Assessments were performed at baseline and Days 7 and 14. Symptoms were assessed using the Atopic Dermatitis Severity Index in Study 2. RESULTS: Body Cream significantly improved skin hydration and reduced itching, burning/stinging, erythema, and tactile roughness. Instant Therapy significantly improved skin hydration and AD symptoms, notably pruritus, erythema, and lichenification. Both products were safe and well tolerated. DISCUSSION: Body Cream and Instant Therapy were effective and well tolerated in the treatment of AD in children. These products provide steroid-free, nonprescription therapy for the maintenance and treatment of acute eczema and were proven effective and safe in infants as young as 3 months.

A Marine Protein-based Dietary Supplement for Subclinical Hair Thinning/Loss: Results of a Multisite, Double-blind, Placebo-controlled Clinical Trial.

INTRODUCTION: Since skin and hair quality are potent vitality signals, and hair growth deficiency can cause significant psychological morbidity. In addition to clearly-defined hair loss disorders, milder forms of hair thinning or hair loss appear to be increasingly common, with a suggestion that sub-optimal diets and stressful lifestyles may be involved. METHODS: Here we assess the value of a dietary marine-extract based dietary supplement in premenopausal women with subclinical hair thinning or hair loss conditions. This multi-site, randomized double-blind, placebo-controlled clinical trial was conducted with impact on hair shedding rate and hair fiber diameter (assessed by phototrichogram) as primary end points upon consumption of the oral supplement compared to a placebo. A total of 96 eligible female subjects were enrolled aged 21-55 years of age from Asian, Caucasian, and Hispanic ethnic backgrounds. RESULTS: This study showed that hair shedding was significantly reduced in the first 3-6 months of daily consumption of the oral supplement. Moreover, phototrichogram image analysis revealed a statistically significant increase in the mean vellus-like hair diameter after 6 months of supplement consumption, when compared to the mean vellus-like hair diameters measured at baseline. DISCUSSION: These results support the view that a nutritional supplement approach may be useful for women in this age group to deal with subclinical hair thinning or hair loss conditions, and those components of this marine extract-based oral supplement may be a useful adjunct.

Hydroquinone-free Skin Brightener System for the Treatment of Moderate-to-severe Facial Hyperpigmentation.

OBJECTIVE: To evaluate the efficacy and tolerability of a multimodal skin-brightening regimen in subjects with facial hyperpigmentation. DESIGN: Open-label, single-center clinical study with clinical assessments at baseline, Week 4, Week 8, and Week 12. TREATMENT: Subjects were instructed to apply the skin-brightening complex onto their facial skin, twice daily, for 12 weeks. Subjects also applied a nonprescription retinol product, moisturizer, and sunscreen. PARTICIPANTS: Twenty-one subjects, aged 41 to 65 years, with Fitzpatrick skin types II to IV and moderate-to-severe facial hyperpigmentation completed the study. MEASUREMENTS: Overall hyperpigmentation and tolerability (objective and subjective) assessments were conducted at all visits. In addition, global improvement in hyperpigmentation was assessed at all follow-up visits. A self-assessment questionnaire was completed by subjects at Week 12. RESULTS: At baseline and Weeks 4, 8, and 12, subjects were assessed for overall hyperpigmentation and global improvement. Standardized digital photographs were also taken of the subjects' facial skin at all visits. Subjects completed a self-assessment questionnaire at Week 12. Statistically significant reductions in mean Overall Hyperpigmentation scores and significant improvements in mean Global Improvement scores compared to baseline were observed at all follow-up visits (all p<0.001). These clinical observations were supported by standardized digital photography. In addition, the skin-brightening regimen was highly rated by subjects on all of the questionnaire parameters. CONCLUSION: The results from this study suggest that the multimodality skin-brightening regimen may provide a comprehensive and optimal treatment option to help reduce facial hyperpigmentation.

SWIRL, a clinically validated, objective, and quantitative method for facial wrinkle assessment.

BACKGROUND: Facial wrinkles are an undesirable feature caused by extrinsic photodamage and intrinsic aging process. Many cosmetic products and esthetic procedures strive to ameliorate the appearance of wrinkles. Currently the effects of those products and procedures on wrinkles are mainly evaluated by clinical grading, subjective self-assessment questionnaires, and optical profilometry of replica impressions. An objective and quantitative method is in demand. METHODS: Raking light optical profilometry was applied directly to facial photography to cast wrinkles as dark shadows. The resulting high-resolution digital images were analyzed using Image Pro software. A high-throughput method, Stephens Wrinkle Imaging using Raking Light (SWIRL), was developed to analyze the severity of wrinkles using photographs taken under the raking light condition. This method was applied to photographs taken from many panelists with a wide range of wrinkle severity scores. The result was compared with clinical grading scores to determine its validity. In addition, this method was applied to photographs taken from panelists before and after product usage to determine its sensitivity. RESULTS: Using the SWIRL method, multiple wrinkle parameters were quantitatively assessed, including wrinkle count, length, width, area, and relative depth. Those parameters correlated well with clinical grading scores, showing correlation coefficient (r value) of about 0.8 for all parameters. This result indicates that the SWIRL method is a valid method for analyzing wrinkle severity. When applied to a clinical study, the SWIRL method was sensitive enough to detect improvement after 8 weeks of product application. CONCLUSIONS: The SWIRL method has been fully validated through clinical studies. It is accurate, objective, and quantitative. As multiple wrinkle parameters are analyzed simultaneously, it can provide more detailed information on how wrinkles change over time and therefore has the potential to shed light on the action and mechanism of antiwrinkle products.

The effect of a vitamin A palmitate and antioxidant-containing oil-based moisturizer on photodamaged skin of several body sites.

BACKGROUND: Cumulative lifetime sun exposure is accepted as having a very important role to play in the expression of the signs of photoaging, which is then superimposed on the intrinsic processes involved in the chronological aging of skin. Many groups have evaluated the effects of emulsion-based products, mostly although not exclusively, on the face using a variety of actives including retinoids and antioxidants. Nevertheless, the effect of a topical anhydrous product on photodamaged skin has not been reported in the literature. AIMS: The objective of this study was to clinically evaluate the effect of a vitamin A palmitate and antioxidant-containing oil-based moisturizer on facial, neck, decolletage, arms, and lower leg body sites. METHODS: In a randomized, controlled and efficacy grader-blinded clinical study conducted over 12 weeks, while at the same time recording the changes in skin condition for a no-treatment group over the same time period, live clinical expert grading of all body sites and also grading of photographs for the face and neck assessed changes in the signs of photodamage was performed for the treatment and no-treatment groups. RESULTS: Compared to the no-treatment group, and to baseline, the oil improved fine lines, coarse wrinkles, mottled pigmentation, uneven skin tone, roughness, firmness, and clarity of the skin on the face and neck and was also shown to improve crepey skin texture, dryness, scaling and roughness on the decolletage, arms and lower legs at the primary end point at 12 weeks (P < 0.001). Moreover, improvements in a variety of parameters were observed as quickly as 2 weeks. In general, the degree of improvement was greatest in the order legs > arms > decolletage > face > neck. CONCLUSIONS: Collectively, these results show the cumulative improvements in the signs of photoaging compared to a no-treatment control group for the oil-based antiaging moisturizer for the first time. The differences in the efficacy of the vitamin A palmiate and antioxidant oil-based moisturizer on different body sites probably reflect the differences in likely photodamage.

A comparison of the tolerability of adapalene 0.1% cream and adapalene 0.1% lotion in healthy individuals.

Two separate single-center, randomized, evaluator-blinded, bilateral (split-face) comparison studies compared the tolerability of adapalene 0.1% cream with adapalene 0.1% lotion in individuals with healthy skin treated once per day for 3 weeks. At each visit, the participants were graded on erythema, scaling, dryness, and stinging/burning (scale: 0 = none to 3 = severe). On the final study visit, the participants completed a Cosmetic Acceptability Questionnaire. Adverse events were recorded at each study visit. A total of 144 participants were enrolled and 130 completed the studies (study 1, n = 66; study 2, n = 64). The lotion formulation was non-inferior to the cream for the success rates and tolerability assessments in both studies. The frequency distributions of worst scores of either 0 (none) or 1 (mild) (study 1; study 2) for adapalene lotion were erythema (98.5%; 40.7%), scaling (100%; 73.5%), dryness (100%; 68.8%), and stinging/burning (98.5%; 100%). The most common treatment-related adverse event was dryness (study 1, cream 2.7% [2 of 75] and lotion 4.0% [3/75]); study 2, cream 2.9% [2 of 69] and lotion 4.3% [3 of 69]. Both the adapalene 0.1% cream and 0.1% lotion formulations were well tolerated and acceptable to the study participants. The adapalene 0.1% lotion provides clinicians with a retinoid for the treatment of acne in a lotion formulation.

Multicenter clinical trial of a home-use nonablative fractional laser device for wrinkle reduction.

BACKGROUND: Until now, nonablative fractional treatments could only be delivered in an office setting by trained professionals. OBJECTIVE: The goal of this work was to perform clinical testing of a nonablative fractional laser device designed for home-use. METHODS: This multicenter trial consisted of two clinical studies with slightly varying treatment protocols in which subjects performed at-home treatments of periorbital wrinkles using a handheld nonablative fractional laser. Both studies included an active treatment phase (daily treatments) and a maintenance phase (twice-weekly treatments). In all, 36 subjects were followed up for as long as 5 months after completion of the maintenance phase and 90 subjects were followed up until the completion of the maintenance phase. Evaluations included in-person investigator assessment, independent blinded review of high-resolution images using the Fitzpatrick Wrinkle Scale, and subject self-assessment. RESULTS: All 124 subjects who completed the study were able to use the device following written instructions for use. Treatments were well tolerated with good protocol compliance. Independent blinded evaluations by a panel of physicians showed Fitzpatrick Wrinkle Scale score improvement by one or more grades in 90% of subjects at the completion of the active phase and in 79% of subjects at the completion of the maintenance phase. The most prevalent side effect was transient posttreatment erythema. LIMITATIONS: Lack of a control group and single-blinded study groups were limitations. CONCLUSION: Safety testing with self-applications by users demonstrated the utility of the device for home use. Independent blinded review of clinical images confirmed the device's proficiency for improving periorbital wrinkles.