- Email: [email protected]
Glutathione as a systemic skin whitening agent via the buccal mucosa: an open-label, single-arm study
3940
2869
Evaluation of key biophysical properties and microscopic structures of 11 crosslinked hyaluronic acid soft tissue fillers before and after needle extrusion, as a proof-of-concept for clinical applicability Hema Sundaram, MD, Sundaram Dermatology, Cosmetic & Laser Surgery Center, Rockville, MD, United States; Samuel Gavard, MMSc, Anteis S.A., Plan-les-Ouates, Switzerland Introduction and objectives: Distinct flow-related (rheologic) and other biophysical properties of different hyaluronic acid (HA) fillers reflect their manufacturing processes and resultant structures; and provide rationale for science-based selection of appropriate fillers for specific clinical applications (rheologic tailoring). They predict in vivo tissue integration patterns, and clinical characteristics including efficacy of nasolabial fold correction. The clinical applicability of biophysical properties depends on their preservation during the injection process. The purpose of this study was to evaluate rheologic properties, cohesivity and microscopic structure of 11 HA fillers before and after needle extrusion. Materials and methods: 3 NASHA, 2 Hylacross, 3 Vycross, and 3 Cohesive Polydensified Matrix (CPM) HA fillers were analyzed. Automated extrusion at 50mm/minute was performed through needles packaged with each product. Cohesivity, a recently defined property, was determined by a new standardized assay developed by the authors, with scoring on a validated 5-point visual scale. Elastic modulus (G’), viscous modulus (G99 ) and complex viscosity (h*) were measured in a parallel plate-plate rheometer at a clinically relevant oscillation frequency of 0.7 Hz. Tan delta (G99 /G’) was calculated. HA structure was examined by optical microscopy of toluidine blue dyed specimens at 40-fold magnification, in association with a high-definition imaging system.
Facial treatment preferences in aesthetically-oriented men Vic Narurkar, MD, Bay Area Laser Institute, San Francisco, CA, United States; Jared Jagdeo, MD, University of California, Davis, Department of Dermatology, Sacramento, CA, United States; Terrence Keaney, MD, George Washington University Hospital, Washington, DC, United States; Conor J. Gallagher, PhD, Allergan, Irvine, CA, United States
Results: For each tested filler, there was no significant difference in cohesivity scores, rheologic values or microstructure before and after extrusion. In contrast, there were significant differences between the 11 fillers. Cohesivity scores ranged from 1 to 5. Cohesivity was lowest for NASHA, low-medium for Vycross, mediumhigh for Hylacross, and highest for CPM HA. Elastic modulus ranged from 60 to 774 Pa. It was highest for NASHA, medium for Vycross, medium-low for Hylacross, and lowest for CPM HA. Filler microstructure was unchanged after extrusion. It varied significantly between fillers, from discrete HA fragments to a reticulated molecular matrix. Conclusions: Key biophysical properties and microstructure of the HA fillers were maintained after extrusion through their associated needles. This supports correlation of these manufacturing attributes with clinical behavior of fillers after tissue implantation. Rheologic tailoring is of value in guiding appropriate technique and depth of injection, to optimize aesthetic outcomes and safety. Evolving understanding links the multifaceted biophysical profile of each filler type to its capacities for 3D tissue support, dynamic restoration and other pivotal characteristics for advanced applications. The predictive relationship between HA microstructure and tissue integration patterns is being investigated further.
Purpose: There is increasing interest in facial aesthetic treatments among men; yet, there is a paucity of data describing male attitudes toward age-related changes to their facial features and associated preferences for prioritizing treatment. Study design: A total of 600 injectable-na€ıve but aesthetically-oriented men between the ages of 30-65 from the United States participated in an online study. Respondents indicated on a 5-point scale how bothered they were by the appearance of 15 agerelated facial features: forehead, glabellar, crow’s feet, marionette, and perioral lines; thinning eyelashes, tear troughs, nasolabial folds, oral commissures, double chin, chin, and jawline; and temple, mid-face, and lip volume loss. The Maximum Difference Scaling System was used to explore: (1) which of these facial features were most likely to be prioritized for treatment, (2) the correlation between the facial features that bothered them and the areas of treatment preference, and (3) agerelated differences in treatment preference categorized in 5-year age cohorts. Results: Respondents had a mean age of 48 years and were mainly white (90%), married (73%), and had at least some college education (95%). Crow’s feet and tear troughs were rated as the most likely to be treated first (each had 80% of first preferences) followed by forehead lines (74%), double chin (70%), glabellar lines (60%), oral commissures (55%), and chin (51%). In comparison, the features rated as the least likely to be treated first were thinning eyelashes (14%), lip volume (15%), and perioral lines (23%). In order, the most bothersome features were tear troughs, double chin, crow’s feet lines, and forehead lines. There was a strong correlation between the facial features that bothered them the most and the areas of treatment priority (r2 ¼ 0.81). All other features were reported as bothersome by less than 10% of the men surveyed, and the features found to be least bothersome to male respondents were lip volume and perioral lines (both 3%). There did not appear to be differences in treatment preferences between younger and older men. Conclusion: These data suggest that among aesthetically-oriented men the periorbital areas, in particular crow’s feet lines and tear troughs, are of most concern and likely to be prioritized for treatment. These areas of concern were common in both younger and older men. This study was sponsored by Allergan plc. Writing assistance was provided to the authors by Julia Kolodziejczyk, PhD of Allergan plc. Neither honoraria nor other form of payments were made for authorship.
Supported 100% by Anteis S.A., a wholly owned subsidiary of Merz Pharmaceuticals GmbH.
3274 Evaluation of the efficacy of a naturally derived facial oil treatment in reducing signs of skin fatigue and protecting skin against age-accelerating oxidative damage Susana Raab, MBA, L’Oreal Research & Innovation, Clark, NJ, United States; Margarita Yatskayer, MS, L’Oreal Research & Innovation, Clark, NJ, United States; Valerie Roberts, PharmD, L’Oreal Research & Innovation, Clark, NJ, United States; Christian Oresajo, PhD, L’Oreal Research & Innovation, Clark, NJ, United States Introduction: Studies have shown that during the course of the day, there is an evolution of skin quality. Signs of skin fatigue appear more noticeable at the end of the day and these signs gradually amplified to become aging signs that set in overtime. Oxidative skin damage is a major contributor to the age accelerating process. The present studies have been conducted to assess the signs of skin fatigue surfacing by the end of the day and to assess the effectiveness of a natural derived facial oil treatment containing sunflower seed, tamanu and ginger root oils in its ability to provide antioxidation benefits and to improve signs of fatigue immediately, over the course of a day and overtime. Method: An instrumental test was performed to assess the antioxidative potential of the facial oil treatment by measuring the UV Induced Chemiluminescence of Human Skin (ICL-S) signal after 2 weeks of product application. In addition, a single-center, 4 weeks clinical study was conducted on 43 women ages 25-45, with mild to moderate skin dullness, roughness, fine lines and overall facial appearance of fatigue/tired look. To evaluate signs of fatigue, clinical efficacy assessments were performed at prebaseline, using a 10-point scale, at hour 0 and hour 8 without product application. At baseline, clinical efficacy assessments were performed at hour 0, immediately and 8 hours after facial oil application to evaluate the short term effect and again at weeks 2 and 4 to evaluate the long term effect. Results: The ICL-S test showed a significant decrease of ICL-S signal confirming the antioxidative potential of the facial oil. Prior to use of the facial oil treatment, a statistically significant worsening for skin fatigue/tired look, fine lines, and radiance/luminosity/glow was observed over a day period (8 hour). After using the facial oil treatment, a statistically significant improvement in clinical grading scores for overall appearance of skin fatigue/tired look, fine lines, radiance/luminosity/glow, and tactile texture was observed immediately after in-clinic application and continued to do so 8 hours later when compared with baseline scores. Improvements were continuously observed after 2 and 4 weeks of use when compared with baseline scores. Supported 100% by L’Oreal.
MAY 2016
3390 Glutathione as a systemic skin whitening agent via the buccal mucosa: an open-label, single-arm study Joyce Castillo, MD, Ramiro Community Hospital, Tagbilaran City, Philippines; Evangeline Handog, MD, Asian Hospital and Medical Center, Muntinlupa, Philippines; Ivan Singzon, MD, St Luke’s Medical Center Global City, Taguig, Philippines; Maria Suzanne Datuin, MD, St Luke’s Medical Center Global City, Taguig, Philippines Background: Skin color is the most apparent phenotypic variation among humans and is primarily determined by the type and amount of melanin synthesized within melanosomes and the pattern of melanosome distribution within the melanocytes. In the Philippines and in most parts of Asia, behavior favoring a lighter skin color has driven the development of a lot of skin whitening products, making it one of the most common forms of body modification practices in the world. Objective: To determine whether glutathione administered through the buccal mucosa at 500 mg per day for 12 weeks is effective and safe as a skin whitening agent. Methods: This open-label, single arm study. Thirty-six otherwise healthy female medical secretaries and hospital personnel with Fitzpatrick skin type IV or V received 500 mg of glutathione daily for 12 weeks administered through the buccal mucosa. The main outcome was mean reduction of melanin indices measured at a sun-exposed area (extensor right wrist) and sun-protected area (mid-sternum) after 12 weeks. The melanin indices were measured again after discontinuing the glutathione for 4 weeks (at week 16). Secondary outcomes were the mean change in melanin indices at 4-week intervals in sun-exposed vs sun-protected areas and abnormalities, if any, in the blood counts and liver enzymes at the end of the study. Statistical significance was determined using t-test. Results: Thirty-four participants completed the study out of thirty-six enrolled subjects. There was a significant decrease in melanin index evident at 4 weeks (for sun-exposed area) and 8 weeks (sun-protected area). The reduction in melanin index is significantly higher in the sun-exposed area that in the sun-protected site. Four weeks after discontinuing glutathione, melanin indices continued to decrease significantly. No serious adverse events were reported and laboratory examinations remained normal. Conclusion: Glutathione administered via the buccal mucosa is an effective and safe method of skin lightening in a small number of Filipino females. The effect is evident even after 4 weeks of discontinuation. However, long-term safety has not been established and placebo-controlled clinical trials are warranted. Supported by Brady Pharma Inc, Manila Philippines.
J AM ACAD DERMATOL
AB17
2869
Evaluation of key biophysical properties and microscopic structures of 11 crosslinked hyaluronic acid soft tissue fillers before and after needle extrusion, as a proof-of-concept for clinical applicability Hema Sundaram, MD, Sundaram Dermatology, Cosmetic & Laser Surgery Center, Rockville, MD, United States; Samuel Gavard, MMSc, Anteis S.A., Plan-les-Ouates, Switzerland Introduction and objectives: Distinct flow-related (rheologic) and other biophysical properties of different hyaluronic acid (HA) fillers reflect their manufacturing processes and resultant structures; and provide rationale for science-based selection of appropriate fillers for specific clinical applications (rheologic tailoring). They predict in vivo tissue integration patterns, and clinical characteristics including efficacy of nasolabial fold correction. The clinical applicability of biophysical properties depends on their preservation during the injection process. The purpose of this study was to evaluate rheologic properties, cohesivity and microscopic structure of 11 HA fillers before and after needle extrusion. Materials and methods: 3 NASHA, 2 Hylacross, 3 Vycross, and 3 Cohesive Polydensified Matrix (CPM) HA fillers were analyzed. Automated extrusion at 50mm/minute was performed through needles packaged with each product. Cohesivity, a recently defined property, was determined by a new standardized assay developed by the authors, with scoring on a validated 5-point visual scale. Elastic modulus (G’), viscous modulus (G99 ) and complex viscosity (h*) were measured in a parallel plate-plate rheometer at a clinically relevant oscillation frequency of 0.7 Hz. Tan delta (G99 /G’) was calculated. HA structure was examined by optical microscopy of toluidine blue dyed specimens at 40-fold magnification, in association with a high-definition imaging system.
Facial treatment preferences in aesthetically-oriented men Vic Narurkar, MD, Bay Area Laser Institute, San Francisco, CA, United States; Jared Jagdeo, MD, University of California, Davis, Department of Dermatology, Sacramento, CA, United States; Terrence Keaney, MD, George Washington University Hospital, Washington, DC, United States; Conor J. Gallagher, PhD, Allergan, Irvine, CA, United States
Results: For each tested filler, there was no significant difference in cohesivity scores, rheologic values or microstructure before and after extrusion. In contrast, there were significant differences between the 11 fillers. Cohesivity scores ranged from 1 to 5. Cohesivity was lowest for NASHA, low-medium for Vycross, mediumhigh for Hylacross, and highest for CPM HA. Elastic modulus ranged from 60 to 774 Pa. It was highest for NASHA, medium for Vycross, medium-low for Hylacross, and lowest for CPM HA. Filler microstructure was unchanged after extrusion. It varied significantly between fillers, from discrete HA fragments to a reticulated molecular matrix. Conclusions: Key biophysical properties and microstructure of the HA fillers were maintained after extrusion through their associated needles. This supports correlation of these manufacturing attributes with clinical behavior of fillers after tissue implantation. Rheologic tailoring is of value in guiding appropriate technique and depth of injection, to optimize aesthetic outcomes and safety. Evolving understanding links the multifaceted biophysical profile of each filler type to its capacities for 3D tissue support, dynamic restoration and other pivotal characteristics for advanced applications. The predictive relationship between HA microstructure and tissue integration patterns is being investigated further.
Purpose: There is increasing interest in facial aesthetic treatments among men; yet, there is a paucity of data describing male attitudes toward age-related changes to their facial features and associated preferences for prioritizing treatment. Study design: A total of 600 injectable-na€ıve but aesthetically-oriented men between the ages of 30-65 from the United States participated in an online study. Respondents indicated on a 5-point scale how bothered they were by the appearance of 15 agerelated facial features: forehead, glabellar, crow’s feet, marionette, and perioral lines; thinning eyelashes, tear troughs, nasolabial folds, oral commissures, double chin, chin, and jawline; and temple, mid-face, and lip volume loss. The Maximum Difference Scaling System was used to explore: (1) which of these facial features were most likely to be prioritized for treatment, (2) the correlation between the facial features that bothered them and the areas of treatment preference, and (3) agerelated differences in treatment preference categorized in 5-year age cohorts. Results: Respondents had a mean age of 48 years and were mainly white (90%), married (73%), and had at least some college education (95%). Crow’s feet and tear troughs were rated as the most likely to be treated first (each had 80% of first preferences) followed by forehead lines (74%), double chin (70%), glabellar lines (60%), oral commissures (55%), and chin (51%). In comparison, the features rated as the least likely to be treated first were thinning eyelashes (14%), lip volume (15%), and perioral lines (23%). In order, the most bothersome features were tear troughs, double chin, crow’s feet lines, and forehead lines. There was a strong correlation between the facial features that bothered them the most and the areas of treatment priority (r2 ¼ 0.81). All other features were reported as bothersome by less than 10% of the men surveyed, and the features found to be least bothersome to male respondents were lip volume and perioral lines (both 3%). There did not appear to be differences in treatment preferences between younger and older men. Conclusion: These data suggest that among aesthetically-oriented men the periorbital areas, in particular crow’s feet lines and tear troughs, are of most concern and likely to be prioritized for treatment. These areas of concern were common in both younger and older men. This study was sponsored by Allergan plc. Writing assistance was provided to the authors by Julia Kolodziejczyk, PhD of Allergan plc. Neither honoraria nor other form of payments were made for authorship.
Supported 100% by Anteis S.A., a wholly owned subsidiary of Merz Pharmaceuticals GmbH.
3274 Evaluation of the efficacy of a naturally derived facial oil treatment in reducing signs of skin fatigue and protecting skin against age-accelerating oxidative damage Susana Raab, MBA, L’Oreal Research & Innovation, Clark, NJ, United States; Margarita Yatskayer, MS, L’Oreal Research & Innovation, Clark, NJ, United States; Valerie Roberts, PharmD, L’Oreal Research & Innovation, Clark, NJ, United States; Christian Oresajo, PhD, L’Oreal Research & Innovation, Clark, NJ, United States Introduction: Studies have shown that during the course of the day, there is an evolution of skin quality. Signs of skin fatigue appear more noticeable at the end of the day and these signs gradually amplified to become aging signs that set in overtime. Oxidative skin damage is a major contributor to the age accelerating process. The present studies have been conducted to assess the signs of skin fatigue surfacing by the end of the day and to assess the effectiveness of a natural derived facial oil treatment containing sunflower seed, tamanu and ginger root oils in its ability to provide antioxidation benefits and to improve signs of fatigue immediately, over the course of a day and overtime. Method: An instrumental test was performed to assess the antioxidative potential of the facial oil treatment by measuring the UV Induced Chemiluminescence of Human Skin (ICL-S) signal after 2 weeks of product application. In addition, a single-center, 4 weeks clinical study was conducted on 43 women ages 25-45, with mild to moderate skin dullness, roughness, fine lines and overall facial appearance of fatigue/tired look. To evaluate signs of fatigue, clinical efficacy assessments were performed at prebaseline, using a 10-point scale, at hour 0 and hour 8 without product application. At baseline, clinical efficacy assessments were performed at hour 0, immediately and 8 hours after facial oil application to evaluate the short term effect and again at weeks 2 and 4 to evaluate the long term effect. Results: The ICL-S test showed a significant decrease of ICL-S signal confirming the antioxidative potential of the facial oil. Prior to use of the facial oil treatment, a statistically significant worsening for skin fatigue/tired look, fine lines, and radiance/luminosity/glow was observed over a day period (8 hour). After using the facial oil treatment, a statistically significant improvement in clinical grading scores for overall appearance of skin fatigue/tired look, fine lines, radiance/luminosity/glow, and tactile texture was observed immediately after in-clinic application and continued to do so 8 hours later when compared with baseline scores. Improvements were continuously observed after 2 and 4 weeks of use when compared with baseline scores. Supported 100% by L’Oreal.
MAY 2016
3390 Glutathione as a systemic skin whitening agent via the buccal mucosa: an open-label, single-arm study Joyce Castillo, MD, Ramiro Community Hospital, Tagbilaran City, Philippines; Evangeline Handog, MD, Asian Hospital and Medical Center, Muntinlupa, Philippines; Ivan Singzon, MD, St Luke’s Medical Center Global City, Taguig, Philippines; Maria Suzanne Datuin, MD, St Luke’s Medical Center Global City, Taguig, Philippines Background: Skin color is the most apparent phenotypic variation among humans and is primarily determined by the type and amount of melanin synthesized within melanosomes and the pattern of melanosome distribution within the melanocytes. In the Philippines and in most parts of Asia, behavior favoring a lighter skin color has driven the development of a lot of skin whitening products, making it one of the most common forms of body modification practices in the world. Objective: To determine whether glutathione administered through the buccal mucosa at 500 mg per day for 12 weeks is effective and safe as a skin whitening agent. Methods: This open-label, single arm study. Thirty-six otherwise healthy female medical secretaries and hospital personnel with Fitzpatrick skin type IV or V received 500 mg of glutathione daily for 12 weeks administered through the buccal mucosa. The main outcome was mean reduction of melanin indices measured at a sun-exposed area (extensor right wrist) and sun-protected area (mid-sternum) after 12 weeks. The melanin indices were measured again after discontinuing the glutathione for 4 weeks (at week 16). Secondary outcomes were the mean change in melanin indices at 4-week intervals in sun-exposed vs sun-protected areas and abnormalities, if any, in the blood counts and liver enzymes at the end of the study. Statistical significance was determined using t-test. Results: Thirty-four participants completed the study out of thirty-six enrolled subjects. There was a significant decrease in melanin index evident at 4 weeks (for sun-exposed area) and 8 weeks (sun-protected area). The reduction in melanin index is significantly higher in the sun-exposed area that in the sun-protected site. Four weeks after discontinuing glutathione, melanin indices continued to decrease significantly. No serious adverse events were reported and laboratory examinations remained normal. Conclusion: Glutathione administered via the buccal mucosa is an effective and safe method of skin lightening in a small number of Filipino females. The effect is evident even after 4 weeks of discontinuation. However, long-term safety has not been established and placebo-controlled clinical trials are warranted. Supported by Brady Pharma Inc, Manila Philippines.
J AM ACAD DERMATOL
AB17