A Cohort Study Using a Facial Cleansing Brush With Acne Cleansing Brush Head and a Gel Cleanser in Subjects With Mild-to-Moderate Acne and Acne-Prone Skin

Introduction: Acne vulgaris is a highly prevalent skin condition that can adversely affect the quality of life. Acne-predisposed skin is in a state of subclinical inflammation leading to skin barrier dysfunction. A multi-center cohort study was designed to evaluate clinical efficacy and safety of twice daily facial cleansing using an oscillatory sonic brush, acne brush head, and cleansing gel for 4 weeks. Methods: Subjects with mild-to-moderate acne and acne-prone skin used the cleansing regime after which they applied the skin care products they routinely used. Physician-assessed skin condition comparing baseline versus week 4 using the FDA/IGA scale and subject satisfaction with cleansing efficacy and handling properties of the regime were scored during the last visit. Results: Forty-six subjects completed the study. Physician-scored skin condition showed a statistically significant improvement in FDA/IGA scores and a significant reduction of inflammatory and non-inflammatory lesions comparing baseline versus 4 weeks. Thirty-five (76.0%) subjects had cleared or almost cleared. Subjects similarly assessed their skin to be improved. Conclusion: Both the physician and subject scores revealed the gentle cleansing routine using the sonic brush to be effective reducing the number of acne lesions, improving skin condition. No adverse events were reported during the study period. The cleansing regime may offer an attractive, safe option for maintenance and treatment of subjects with mild-to-moderate acne and acne-prone skin. J Drugs Dermatol. 2019;18(11):1140-1145.

Expert Consensus on Cosmetic Outcomes After Treatment of Actinic Keratosis.

Dermatologists treat actinic keratosis (AK) primarily because these lesions have the potential to progress to invasive squamous cell carcinoma. Patients, on the other hand, generally seek treatment to remove the lesions and achieve an improved appearance of their skin following treatment. In selecting a treatment option for AK, dermatologists should consider post-treatment cosmesis, because cosmetic outcomes differ across AK treatments. To obtain expert opinion on the cosmetic sequelae related to chronically photodamaged skin and the treatment of AK, an expert panel meeting among dermatologists was conducted in February 2016. These experts reviewed current treatment options for photodamage, including AK, and discussed the relative merits of the various cosmetic assessments commonly used by investigators and patients in both clinical trial and dermatology practice settings. A main goal of the expert panel meeting was to propose assessment tools that could be specifically designed to characterize cosmesis results after treatment of AK. The panel agreed that existing tools for measurement of cosmetic outcomes following treatment of photodamage could also be used to evaluate cosmesis after treatment of AK. Digital photography is probably the best method used for this, with validation by other technologies. Better measurement tools specifically for assessing cosmesis after AK treatment are needed. Once they are developed and validated, regulatory agencies should be educated about the importance of including cosmetic outcomes as a component of product labeling.

J Drugs Dermatol. 2017;16(3):260-265.

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.

The Frontalis Activity Measurement Standard: a novel contralateral method for assessing botulinum neurotoxin type-A activity.

BACKGROUND: There are conflicting data regarding the specific attributes of botulinum neurotoxin type-A (BoNTA) products including onset of action, duration and spread because accurate, objective methods for assessing their clinical activity are lacking. OBJECTIVE: To refine definitions for BoNTA activity utilizing the frontalis muscle and describe the Frontalis Activity Measurement Standard (FMS), an objective method for measuring changes in frontalis muscle activity as a metric for assessing BoNTA pharmacodynamics. METHODS: As part of a study to assess BoNTA activity, 20 subjects with severe frontalis lines at maximum elevation were injected with two BoNTA products at five points on contralateral sides of the frontalis. Changes in maximum baseline frontalis elevation were measured by a blinded investigator using the previously-validated Frontalis Rating Scale (FRS) and the FMS. Frontalis activity endpoints were redefined to include Initial, Full and Complete Onsets of action and Partial, Full and Complete efficacy. RESULTS: Differences in the onset of effect of the BoNTA products were detected with both the FRS and FMS; however, the FMS detected changes in frontalis activity earlier than the FRS. A significant correlation between the FRS and FMS was documented. CONCLUSION: The frontalis muscle activity allows for enhanced assessment of BoNTA activity and attributes. The FMS appears to be a sensitive and objective tool for measuring pharmacodynamic parameters of BoNTA. Refining definitions of BoNTA activity provides a more accurate means for describing the clinical effects of BoNTA.

Comparing the clinical attributes of abobotulinumtoxinA and onabotulinumtoxinA utilizing a novel contralateral Frontalis model and the Frontalis Activity Measurement Standard.

BACKGROUND: Studies on the pharmacodynamics of abobotulinumtoxinA (ABO) and onabotulinumtoxinA (ONA) have produced inconsistent results. This may be due to the lack of objective measurement methods. OBJECTIVE: To assess and compare pharmacodynamic attributes, including onset of action, spread and efficacy of ABO and ONA using a novel Frontalis Activity Measurement Standard (FMS) and 4-point Frontalis Rating Scale (FRS). METHODS: Twenty subjects with severe frontalis lines at maximum elevation received equal volumes of ABO or ONA using a dose ratio of 2.5:1 in five injection points on contralateral sides of the frontalis (statistical n=40). Subjects were evaluated using the FMS and FRS for 30 days using pre-defined endpoints for onset and effectiveness. Other assessments included areas of effectiveness and injection pain. RESULTS: For ABO vs. ONA, the FMS revealed a median Initial Onset of 12 vs. 48 hours (P is less than 0.001), Full Onset of 24 vs. 72 hours (P is less than 0.001) and Complete Onset of three vs. five days (P=0.01). The FRS indicated an Initial Onset for ABO and ONA of 18 hours vs. two days (P=0.002), Full Onset of two vs. three days (P=0.001) and Complete Onset of four days vs. eight days (P=0.01). The FMS showed 90 percent of ABO treatment achieved Complete Efficacy vs. 75 percent for ONO, while 90 percent of ABO treatments reached Complete Efficacy using the FRS vs. 65 percent for ONO. No differences in area of effectiveness or spread were observed. Most subjects (80%) reported ABO injections were less painful than ONA injections (P< 0.05). CONCLUSION: The FMS appears to be a sensitive, objective tool for measuring ABO and ONA pharmacodynamics. Using a dose ratio of 2.5:1, ABO displayed significantly earlier onset of effect and less injection pain than ONA but similar areas of effectiveness.

Duration of action of abobotulinumtoxina and onabotulinumtoxina: a randomized, double-blind study using a contralateral frontalis model.

OBJECTIVE: To measure and compare the duration of action of abobotulinumtoxinA and onabotulinumtoxinA. DESIGN: Randomized, double-blind, contralateral (split-face) study. SETTING: Two United States clinical sites. PARTICIPANTS: Twenty subjects with severe frontalis lines at maximum elevation. MEASUREMENTS: Subjects randomly received equal volumes of abobotulinumtoxinA or onabotulinumtoxinA (0.2mL) in five injection points on contralateral sides of the frontalis (N=40) using a dose ratio of 2.5:1.0 (total 25U abobotulinumtoxinA:10U onabotulinumtoxinA), respectively. Subjects were evaluated using a 4-point Frontalis Rating Scale and a new objective Frontalis Activity Measurement Standard for 210 days using predefined endpoints for efficacy. RESULTS: Using the Frontalis Activity Measurement Standard, the median duration of "complete efficacy" was 72 days for abobotulinumtoxinA and 56 days for onabotulinumtoxinA (p=0.01), "full efficacy" was 103 days for abobotulinumtoxinA and 87 days for onabotulinumtoxinA (p<0.003), and "partial efficacy" was 105 days for abobotulinumtoxinA and 99 days for onabotulinumtoxinA (p=0.006). Using the Frontalis Rating Scale, the median duration of "complete efficacy" was 63 days for abobotulinumtoxinA and 44 days for onabotulinumtoxinA (p=0.006), "full efficacy" was 119 days for abobotulinumtoxinA and 77 days for onabotulinumtoxinA (p=0.005), and "partial efficacy" was 160 days for abobotulinumtoxinA and 145 days for onabotulinumtoxinA (p=NS). Adverse events included local bruising and occasional headache, but no significant inter-group differences. CONCLUSION: The contralateral Frontalis Activity Measurement Standard is well-suited for assessing the pharmacodynamic and clinical attributes of botulinum toxin type A and can be used to measure differences in the clinical properties of abobotulinumtoxinA and onabotulinumtoxinA. Using a dose ratio of 2.5:1.0, abobotulinumtoxinA displayed significantly longer duration of action than onabotulinumtoxinA.

The use of a contact cooling device to reduce pain and ecchymosis associated with dermal filler injections.

Objectives. Consensus guidelines developed for the use of hyaluronic acid dermal fillers describe the use of cooling the skin to reduce patient discomfort during injection. The vasoconstrictive effects of cold may provide reduced ecchymosis and swelling at the site. However, the effect of applying ice or cooled air is unpredictable because these modalities do not deliver precise temperature, which may result in cold burn or insufficient effect to targeted areas. This open-label, randomized, single-blinded, split-face trial was conducted to measure the extent to which applying a spot cooling device reduces patient discomfort and ecchymoses in the clinical setting in patients undergoing a dermal filler procedure. Subjects. Twenty male and female subjects of any race, ages 35 to 65 years, with moderate and severe nasolabial folds were included in this study. Seven (35%) subjects had received previous small gel particle hyaluronic acid injections. Methods. Prior to injection, the topical cooling system was set at 35 degrees F and a cooled applicator was applied for 20 seconds on one nasolabial fold. A control using a noncooled applicator was applied for 20 seconds on the other nasolabial fold. Postprocedure ice packs were prohibited so as not to confound the subject's perception of procedure-related pain. Subjects (using visual analog pain scales) and blinded investigators rated pain and ecchymosis using predetermined scales and satisfaction surveys. Results. Use of the cooling system was associated with mean pain reduction of 61, 70, and 42 percent compared to control, as measured by visual analog pain scales, immediately following and one hour and three hours post small gel particle hyaluronic acid injection. Additionally, use of the cooling system was associated with mean ecchymosis reduction of 88, 89, 80, and 66 percent compared to control immediately following injection, one hour, three hours, and next-day postinjection. Conclusion. The cooling system provided adequate pain management (both subjectively and objectively through blinded evaluations) during and after small gel particle hyaluronic acid dermal filler injections for the correction of moderate nasolabial folds. Furthermore, results demonstrate that the cooling system is associated with decreased ecchymosis. Future studies are needed comparing the use of topical anesthetics to a cooling system for the reduction of pain and ecchymosis associated with the use of dermal filler injections.