- Email: [email protected]
A study evaluating cohesive polydensified matrix hyaluronic acid filler for the treatment of etched-in fine facial lines: 12 week data
5403
5292
A single-center, evaluator-blinded, split-face, randomized, controlled clinical study to assess the efficacy and tolerability of a low frequency, handheld ultrasound cosmetic product used in conjunction with a topical skin care regimen Sheree Wiener, RN, Arbonne International; Robert Bianchini, PhD, Arbonne International; Thomas Stephens, PhD, Thomas J. Stephens, PhD; Michael Babcock, MD, Thomas J. Stephens & Associates; Kun ‘‘Mark’’ Qian, MD, Thomas J. Stephens & Associates Objective: To assess, the immediate effects and over the course of 30 days, the efficacy, tolerability, and skin wellness benefits of the Sponsor’s (patent-pending) low frequency, diffuse ultrasound handheld product as part of a cosmetic regimen with a lifting and contouring eye cream or renewal serum when used by women with mild to moderate facial photodamage.
A split-face design clinical trial to evaluate the efficacy of a masque when used postefull face nonablative fractionated laser treatment Ana Du, BS, L’Oreal USA Research and Innovation; Susana Raab, BS, L’Oreal USA Research and Innovation; Margarita Yatskayer, MS, L’Oreal USA Research and Innovation; Stephen Lynch, PhD, L’Oreal USA Research and Innovation Introduction: Factors such as dermatologic or aesthetic procedures, sun or wind exposure, and environmental aggressors can catalyze a state of temporary skin reactivity which leads to the appearance of redness, heat sensations and general discomfort. The goal of the present study was to evaluate the clinical effects of a facial masque designed to comfort and soothe skin following a popular aesthetic procedure.
Methods: Cell 1: 26 subjects with mild to moderate periocular wrinkles and under eye skin dark circles and/or puffiness, roughness, and dullness/lack of radiance. Cell 2: 25 subjects with mild to moderate facial and periocular fine lines and/or wrinkles, facial skin dullness/lack of radiance, roughness, and mottled pigmentation. During the course of the study, all subjects used the support facial cleanser and SPF 30 sunscreen. Subjects, applied the test article, let dry and then contacted the Sponsor’s ultrasound handheld product on the assigned side of the face (right or left according to predetermined randomization) for 1 minute twice a day for 30 days. Assessments including clinical grading, bio-instrumentation, photographs and subject self-assessment questionnaires were conducted at visit 1 (baseline), visit 2 (day 3), and visit 3 (day 30). Conclusion: Overall results indicated that the lifting and contouring eye cream (cell 1) and renewal serum (cell 2), when used with and without the Sponsor’s low frequency handheld ultrasound product, was well tolerated, and was effective in improving the appearance of the face and eye area. In addition, improvements were seen in moisturization, overall skin appearance and skin texture.
Method: This single center, split-face clinical trial was conducted over the course of 1 day on thirty (30) female subjects between the ages of 32-60. Each subject was treated with a non-ablative fractionated laser treatment. The tested masque was applied by a clinician on the assigned side of the face according to a predetermined randomization. Clinical evaluations of the appearance of redness, dryness, flaking/ peeling and swelling were conducted prelaser, postlaser, postproduct application and postproduct rinse off. Local cutaneous tolerability was evaluated by subject assessment of signs and symptoms of pain/discomfort, itching, burning, heat sensation and tightness separately for the facial halves. Digital images were taken at each of the designated study time points using a thermal camera and VISIA CR system. Subjects also completed a questionnaire in regards to the cooling/calming/ soothing effects post masque application. Results: The results from this study indicated that the tested masque was effective in improving the appearance of redness and reducing pain/discomfort, burning, heat sensation, and tightness on the treated side post-product application and/or postproduct rinse off when compared to baseline and between the treated and untreated sides. Additionally, results of thermal imaging showed a statistically significant reduction in skin surface temperature on the cheek of the treated side at post-product application and rinse off when compared to baseline (postlaser) and when compared to the untreated side of the face. Subjects also indicated feeling cool and feeling calmed/soothed immediately upon masque application.
Commercial support: Arbonne International paid 100%.
Commercial support: None identified.
5768 A smartphone application for psoriasis management Fartash Vasefi, PhD, eTreatMD Inc.; Nicholas MacKinnon, BS, eTreatMD Inc; Timothy Horita, BS, eTreatMD Inc.; Kevin Shi, BS, eTreatMD Inc.; Tamanna Tabassum Khan Munia, MS, University of North Dakota; Kouhyar Tavakolian, PhD, University of North Dakota; Daniel Farkas, PhD, Spectral Molecular Imaging Inc.; Reza Fazel Rezai, PhD, University of North Dakota Psoriasis is a chronic skin disease affecting approximately 125 million people worldwide. Currently, dermatologists monitor changes of psoriasis by clinical evaluation or by measuring psoriasis severity scores over time which lead to subjective management of this condition. The goal of this paper is to develop a reliable assessment system to quantitatively assess the changes of erythema, thickness and intensity of scaling of psoriatic lesions. A smartphone deployable mobile application is presented that uses the smartphone camera and cloud-based image processing to analyze physiological characteristics of psoriasis lesions, identify the type and stage of the scaling and erythema. The application targets to automatically evaluate Psoriasis Area Severity Index (PASI) and Physician’s Global Assessment (PGA) by measuring the severity and extent of psoriasis. The mobile application performs the following core functions: 1) it captures text information from user input to create a profile in a HIPAA compliant database. 2) It captures an image of the skin with psoriasis as well as image-related information entered by the user. 3) The application color corrected the image based on environmental lighting condition using calibration process including calibration procedure by capturing Macbeth ColorChecker image. 4) The color-corrected image will be transmitted to a cloud-based engine for image processing. In cloud, first, the algorithm removes the non-skin background to ensure the psoriasis segmentation is only applied to the skin regions. Then, the psoriasis segmentation algorithm estimates the erythema and scaling boundary regions of lesion. Morphological characteristic of skin lesion such as thickness is estimated which represents one of the severity conditions. We analyzed 10 images of psoriasis images captured by cellphone, determined PASI and PGA score for each subject during our pilot study, and correlated it with changes in severity scores given by dermatologists. The smartphone images will be also compared with a more comprehensive/multimode dermoscope. By using hyperspectral and polarization imaging, we provide quantitative and depth based information on tissue chromophore distribution and tissue surface architecture. The success of this work allows smartphone application for psoriasis severity assessment in a long-term treatment.
A study evaluating cohesive polydensified matrix hyaluronic acid filler for the treatment of etched-in fine facial lines: 12 week data Jeanette Black, MD, Skin Care and Laser Physicians of Beverly Hills; Derek Jones, MD, Skin Care and Laser Physicians of Beverly Hills Can cohesive polydensified matrix hyaluronic acid (CPM HA, Belotero Balance, Merz) filler be used to treat etched-in fine lines in multiple facial areas? We report clinical outcomes and patient satisfaction at 12 weeks following treatment of etchedin fine lines in key facial areas using CPM HA blended with 0.1ml lidocaine with epinephrine per 1.0ml of CPM HA. After informed consent, patients received intradermal injections of CPM HA filler in up to 5 facial areas: cutaneous lip (CL), radial cheek (RC), nasolabial folds (NL), melolabial folds (ML), and/or forehead (FH). Patients returned after 2 weeks for an optional touch-up treatment. Following each treatment, patients used a diary to record the occurrence of injection site reactions of pain, bruising, swelling, redness, and lumpiness. At 12 and 24 weeks after the final treatment, outcomes were evaluated by the treating physician using Merz Aesthetic Validated Assessment Scales and Lemperle Facial Wrinkle Scales, and by patients using a 4-point scale indicating the percent improvement from baseline. 31 subjects participated in the study. Half (52%) received treatment to at least 3 areas. Average injection volume, number receiving treatment (and percent receiving touch-up treatment) for the 5 areas were CL: 1.1 mL, n ¼ 17 (65%), RC: 1.4 mL, n ¼ 16 (75%), ML: 0.9 mL, n ¼ 17 (87%), NL: 0.8 mL, n ¼ 15 (88%), and FH: 0.9 mL, n ¼ 17 (88%). At Week 12 all 5 treatment areas showed clinically meaningful and statistically significant improvements in average clinical ratings (all P \.01). The change from baseline ratings on the 5-point scales for the 5 areas: CL: -1.5 (2.1), RC: -2.0 (2.6), NL: -1.5 (2.9), ML: -1.7 (3.0), and FH: -1.5 (3.0). The majority of patients reported substantial improvement. The percent of patients reporting at least a 50% improvement from baseline for the same 5 areas was 88%, 94%, 65%, 80%, and 71%, respectively. Injection site reactions were consistent with the class of dermal fillers. Bruising was reported by 47% of patients with lip treatment, but lasted only 2.9 days. Swelling, redness, and lumpiness were reported with forehead treatment, lasting on average 3.0, 3.1, and 6.8 days, respectively. Mild injection pain was reported for most treatment areas; incidence of persistent pain was low for all areas. These results confirm that CPM HA filler is an effective treatment option for etchedin fine facial lines with clinical improvement sustained at 12 weeks. Week 24 results will be reported upon study completion.
Commercial support: 100% paid by eTreatMD Inc.
Commercial support: A research grant was provided by Merz North America.
JUNE 2017
5291
J AM ACAD DERMATOL
AB27
5292
A single-center, evaluator-blinded, split-face, randomized, controlled clinical study to assess the efficacy and tolerability of a low frequency, handheld ultrasound cosmetic product used in conjunction with a topical skin care regimen Sheree Wiener, RN, Arbonne International; Robert Bianchini, PhD, Arbonne International; Thomas Stephens, PhD, Thomas J. Stephens, PhD; Michael Babcock, MD, Thomas J. Stephens & Associates; Kun ‘‘Mark’’ Qian, MD, Thomas J. Stephens & Associates Objective: To assess, the immediate effects and over the course of 30 days, the efficacy, tolerability, and skin wellness benefits of the Sponsor’s (patent-pending) low frequency, diffuse ultrasound handheld product as part of a cosmetic regimen with a lifting and contouring eye cream or renewal serum when used by women with mild to moderate facial photodamage.
A split-face design clinical trial to evaluate the efficacy of a masque when used postefull face nonablative fractionated laser treatment Ana Du, BS, L’Oreal USA Research and Innovation; Susana Raab, BS, L’Oreal USA Research and Innovation; Margarita Yatskayer, MS, L’Oreal USA Research and Innovation; Stephen Lynch, PhD, L’Oreal USA Research and Innovation Introduction: Factors such as dermatologic or aesthetic procedures, sun or wind exposure, and environmental aggressors can catalyze a state of temporary skin reactivity which leads to the appearance of redness, heat sensations and general discomfort. The goal of the present study was to evaluate the clinical effects of a facial masque designed to comfort and soothe skin following a popular aesthetic procedure.
Methods: Cell 1: 26 subjects with mild to moderate periocular wrinkles and under eye skin dark circles and/or puffiness, roughness, and dullness/lack of radiance. Cell 2: 25 subjects with mild to moderate facial and periocular fine lines and/or wrinkles, facial skin dullness/lack of radiance, roughness, and mottled pigmentation. During the course of the study, all subjects used the support facial cleanser and SPF 30 sunscreen. Subjects, applied the test article, let dry and then contacted the Sponsor’s ultrasound handheld product on the assigned side of the face (right or left according to predetermined randomization) for 1 minute twice a day for 30 days. Assessments including clinical grading, bio-instrumentation, photographs and subject self-assessment questionnaires were conducted at visit 1 (baseline), visit 2 (day 3), and visit 3 (day 30). Conclusion: Overall results indicated that the lifting and contouring eye cream (cell 1) and renewal serum (cell 2), when used with and without the Sponsor’s low frequency handheld ultrasound product, was well tolerated, and was effective in improving the appearance of the face and eye area. In addition, improvements were seen in moisturization, overall skin appearance and skin texture.
Method: This single center, split-face clinical trial was conducted over the course of 1 day on thirty (30) female subjects between the ages of 32-60. Each subject was treated with a non-ablative fractionated laser treatment. The tested masque was applied by a clinician on the assigned side of the face according to a predetermined randomization. Clinical evaluations of the appearance of redness, dryness, flaking/ peeling and swelling were conducted prelaser, postlaser, postproduct application and postproduct rinse off. Local cutaneous tolerability was evaluated by subject assessment of signs and symptoms of pain/discomfort, itching, burning, heat sensation and tightness separately for the facial halves. Digital images were taken at each of the designated study time points using a thermal camera and VISIA CR system. Subjects also completed a questionnaire in regards to the cooling/calming/ soothing effects post masque application. Results: The results from this study indicated that the tested masque was effective in improving the appearance of redness and reducing pain/discomfort, burning, heat sensation, and tightness on the treated side post-product application and/or postproduct rinse off when compared to baseline and between the treated and untreated sides. Additionally, results of thermal imaging showed a statistically significant reduction in skin surface temperature on the cheek of the treated side at post-product application and rinse off when compared to baseline (postlaser) and when compared to the untreated side of the face. Subjects also indicated feeling cool and feeling calmed/soothed immediately upon masque application.
Commercial support: Arbonne International paid 100%.
Commercial support: None identified.
5768 A smartphone application for psoriasis management Fartash Vasefi, PhD, eTreatMD Inc.; Nicholas MacKinnon, BS, eTreatMD Inc; Timothy Horita, BS, eTreatMD Inc.; Kevin Shi, BS, eTreatMD Inc.; Tamanna Tabassum Khan Munia, MS, University of North Dakota; Kouhyar Tavakolian, PhD, University of North Dakota; Daniel Farkas, PhD, Spectral Molecular Imaging Inc.; Reza Fazel Rezai, PhD, University of North Dakota Psoriasis is a chronic skin disease affecting approximately 125 million people worldwide. Currently, dermatologists monitor changes of psoriasis by clinical evaluation or by measuring psoriasis severity scores over time which lead to subjective management of this condition. The goal of this paper is to develop a reliable assessment system to quantitatively assess the changes of erythema, thickness and intensity of scaling of psoriatic lesions. A smartphone deployable mobile application is presented that uses the smartphone camera and cloud-based image processing to analyze physiological characteristics of psoriasis lesions, identify the type and stage of the scaling and erythema. The application targets to automatically evaluate Psoriasis Area Severity Index (PASI) and Physician’s Global Assessment (PGA) by measuring the severity and extent of psoriasis. The mobile application performs the following core functions: 1) it captures text information from user input to create a profile in a HIPAA compliant database. 2) It captures an image of the skin with psoriasis as well as image-related information entered by the user. 3) The application color corrected the image based on environmental lighting condition using calibration process including calibration procedure by capturing Macbeth ColorChecker image. 4) The color-corrected image will be transmitted to a cloud-based engine for image processing. In cloud, first, the algorithm removes the non-skin background to ensure the psoriasis segmentation is only applied to the skin regions. Then, the psoriasis segmentation algorithm estimates the erythema and scaling boundary regions of lesion. Morphological characteristic of skin lesion such as thickness is estimated which represents one of the severity conditions. We analyzed 10 images of psoriasis images captured by cellphone, determined PASI and PGA score for each subject during our pilot study, and correlated it with changes in severity scores given by dermatologists. The smartphone images will be also compared with a more comprehensive/multimode dermoscope. By using hyperspectral and polarization imaging, we provide quantitative and depth based information on tissue chromophore distribution and tissue surface architecture. The success of this work allows smartphone application for psoriasis severity assessment in a long-term treatment.
A study evaluating cohesive polydensified matrix hyaluronic acid filler for the treatment of etched-in fine facial lines: 12 week data Jeanette Black, MD, Skin Care and Laser Physicians of Beverly Hills; Derek Jones, MD, Skin Care and Laser Physicians of Beverly Hills Can cohesive polydensified matrix hyaluronic acid (CPM HA, Belotero Balance, Merz) filler be used to treat etched-in fine lines in multiple facial areas? We report clinical outcomes and patient satisfaction at 12 weeks following treatment of etchedin fine lines in key facial areas using CPM HA blended with 0.1ml lidocaine with epinephrine per 1.0ml of CPM HA. After informed consent, patients received intradermal injections of CPM HA filler in up to 5 facial areas: cutaneous lip (CL), radial cheek (RC), nasolabial folds (NL), melolabial folds (ML), and/or forehead (FH). Patients returned after 2 weeks for an optional touch-up treatment. Following each treatment, patients used a diary to record the occurrence of injection site reactions of pain, bruising, swelling, redness, and lumpiness. At 12 and 24 weeks after the final treatment, outcomes were evaluated by the treating physician using Merz Aesthetic Validated Assessment Scales and Lemperle Facial Wrinkle Scales, and by patients using a 4-point scale indicating the percent improvement from baseline. 31 subjects participated in the study. Half (52%) received treatment to at least 3 areas. Average injection volume, number receiving treatment (and percent receiving touch-up treatment) for the 5 areas were CL: 1.1 mL, n ¼ 17 (65%), RC: 1.4 mL, n ¼ 16 (75%), ML: 0.9 mL, n ¼ 17 (87%), NL: 0.8 mL, n ¼ 15 (88%), and FH: 0.9 mL, n ¼ 17 (88%). At Week 12 all 5 treatment areas showed clinically meaningful and statistically significant improvements in average clinical ratings (all P \.01). The change from baseline ratings on the 5-point scales for the 5 areas: CL: -1.5 (2.1), RC: -2.0 (2.6), NL: -1.5 (2.9), ML: -1.7 (3.0), and FH: -1.5 (3.0). The majority of patients reported substantial improvement. The percent of patients reporting at least a 50% improvement from baseline for the same 5 areas was 88%, 94%, 65%, 80%, and 71%, respectively. Injection site reactions were consistent with the class of dermal fillers. Bruising was reported by 47% of patients with lip treatment, but lasted only 2.9 days. Swelling, redness, and lumpiness were reported with forehead treatment, lasting on average 3.0, 3.1, and 6.8 days, respectively. Mild injection pain was reported for most treatment areas; incidence of persistent pain was low for all areas. These results confirm that CPM HA filler is an effective treatment option for etchedin fine facial lines with clinical improvement sustained at 12 weeks. Week 24 results will be reported upon study completion.
Commercial support: 100% paid by eTreatMD Inc.
Commercial support: A research grant was provided by Merz North America.
JUNE 2017
5291
J AM ACAD DERMATOL
AB27