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A multicenter clinical evaluation of the performance of fractional radiofrequency technology for improvement of skin texture
1677
1457
Trauma-focused CBT for a patient with Acne Excoriee: A case report Reena Shah, Barts Health NHS Trust, London, United Kingdom; Alia Ahmed, MBChB, Barts Health NHS Trust, London, United Kingdom; Anthony Bewley, MBChB, Barts Health NHS Trust, London, United Kingdom Introduction: Acne excoriee (AE) is considered to be self-inflicted dermatoses where patients openly report having the compulsive urge to manipulate the acne and picking imagined papules causing the acne to spread. The condition can be chronic, recurring, and often resistant to standard dermatologic and psychiatric treatment. Patients may exhibit two entities: habitual and emotional picking. Habit reversal and relaxation has been shown to be useful for those with AE. However, sometimes there are underlying causes to the picking, such as traumatic memories/flashbacks. In these circumstances, conducting relaxation for the emotional picking can be detrimental as this can exacerbate flashbacks. Methods: A retrospective case review of a patient presenting to a psychodermatology service, specifically to the clinical psychologist. Sessions included patient assessment and trauma-focussed CBT (tf-CBT). Standardized measures were administered pre- and postintervention.
A multicenter clinical evaluation of the performance of fractional radiofrequency technology for improvement of skin texture Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States
Results: A Caucasian female (aged 32) was referred for psychological assessment and treatment after medical treatment was unsuccessful (including phototherapy and topical treatment). She remained on psychiatric medication throughout therapy due to her psychiatric history. The acne and picking started when she was 10 years old. She experienced sexual abuse and verbal aggression from age 5 to 25 years. She had flashbacks of traumatic experiences and her main coping mechanism was to dissociate and pick her acne. One-to-one tf-CBT (16 sessions) was conducted concentrating on the traumatic experiences. Outcome scores indicated a decrease in appearance concern, anxiety and depression and increased quality of life. There was a significant reduction in flashbacks and being able to manage them better and a termination of the picking. Conclusion: Treating patients with AE can be challenging sometimes due to underlying psychological factors perpetuating the picking. It is crucial to gain a high level of trust with patients in order to establish full histories when conducting detailed psychological assessments. It is important to dis/confirm possible underlying causes as some psychological techniques can be detrimental to the patient. Hence a referral to a psychologist and using established psychological interventions can reduce picking and optimise care. To our knowledge, this is the first reported case report of a using a psychological intervention to treat flashbacks to consequently reduce AE.
Introduction and objectives: The visible reduction in the appearance of the acne scars, skin texture irregularities, and or rhytides. Seventy-five centers in North America and 1 hospital in Israel, participated in an IRB approved, multicenter study using a fractional radio frequency (RF) device to treat skin textural irregularities. Materials and methods: Enrollment consisted of both genders (aged 21-60) and all Fitzpatrick skin types and up to 390 patients. Patients were treated with an RF scanner using parallel rows of pins in a rectangular pattern. There are 160 pins per tip covering 150 by 20 micron footprint, 700 microns in height with a 30 degree angle. Scanner deliver of the RF energy allows the applicator to have 4 pins active electrodes while 156 pins are return electrodes. Patients were pretreated with a mild topical anesthetic to allow for additional comfort. One pass of energy pulses is completed over the subjects’ face ensuring that the footprint of each tip pulse is adjacent and not overlapping more than 10%. Posttreatment patients were instructed to use a posttreatment barrier cream and sunblock on subsequent days where sun exposure will be a concern. Treatments are repeated 3 times with an interval of one treatment every 2 weeks on the face. Subjective observations were documented through patient satisfaction and improvement assessment surveys as well as GAI (global assessment improvement scale) photographic assessment was performed by the physicians at the two months post treatment period. Results: At the 1-month follow-up, an average of 73% of patients have observed a visible improvement in their skin with the score increasing to 80% at the 2-month follow-up period. Physicians scored for global assessment were consistent between physicians and remained relatively the same between the 1 month and 2 month follow-up period. Significant improvement has been observed in pigmentation abnormalities but further study is required to establish the device’s efficacy for melasma, solar lentigo, or lentigo senilis. Conclusions: Scanner delivered RF technology can be used with a high degree of confidence to improve the textural appearance of the skin with little downtime and a high degree of patient satisfaction. Consultant and performed research for Venus Concepts.
Commercial support: None identified.
901
AESTHETIC DERMATOLOGY 1742 A 16-week single blind trial evaluating the efficacy of a topical product on skin parameters on older subjects with thin/fragile skin Stephen Schwartz, MS, International Research Services, Inc, Port Chester, NY, United States; Tim McCraw, PhD, Kimberly Clarke Corporation, Roswell, GA, United States; Robert Frumento, Port Chester, NY, United States Background: Thin, fragile skin is a common condition in older adults. The condition can lead to a number of problems, from an aged appearance and a loss of firmness and elasticity to tearing and sensitivity that leads to easy bruising. Mechanistically, collagen and elastin production slows down as we age, making skin drier and less pliable and skin is therefore more prone to wrinkling and scaling, many older adults become upset at the appearance of their skin. Several topical consumer products are available that claim to improve this process, however published data is limited. Methods: This was a 16-week monadic evaluation of one facial skin treatment serum. One test product was used with a standardized supporting moisture product on a panel of forty-eight subjects prequalified as having thin/fragile skin. Instrumental assessments including Cutometer (MPA 580; Courage+Khazaka, Cologne Germany), Ultrasound (DermaScan C; Cortex Technology, Hadsund, Denmark), Clarity Image Analysis (BTBP, San Jose, CA), and SIAscope (MedX; Mississauga, ON, Canada) were performed at visits on weeks 0, 4, 8, 12, and 16. Data from these assessments were utilized for analysis of intended product efficacy. Results: Subject demographics are shown in Table I. The average age of subjects enrolled was 57.62 years. Cutometer results showed early improvements after 4 weeks of use in firmness and elasticity (51.55% and 49.47% improvement, respectively), subjects having these improvements steadily increased throughout the trial. SIAscope collagen data (Table II) showed significant improvements after 12 and 16 weeks of use. Ultrasound data, similarly, showed significant improvements in skin thickness after 12 and 16 weeks of use, echogenicity were numerically improved. Clarity image analysis showed significant improvements in total lines/wrinkles, fine line wrinkles, deep line wrinkles, and the average length and width of wrinkles and in both the crow’s feet region and globally after 16 weeks of product use.
A randomized vehicle-controlled proof-of-concept study of human cathepsin-L injections for the treatment of edematous fibrosclerotic panniculopathy (cellulite) Francisco Perez Atamoros, MD, Centro Dermatol ogico, Miguel Hidalgo, Mexico; Daniel N. Sauder, MD, University of Ottawa, Ottawa, Ontario, Canada; Sonia Barrezueta Chea, MD, Centro Dermatol ogico, Miguel Hidalgo, Mexico; Claudio Castillo Martinez, MD, Centro Dermatol ogico, Miguel Hidalgo, Mexico; Daniel J. Piacquadio, MD, Therapeutics Incorporated, San Diego, CA, United States; David Conway, MS, Halozyme Therapeutics, San Diego, CA, United States; Gilbert A. Keller, PhD, Halozyme Therapeutics, San Diego, CA, United States; Daniel E. Vaughn, PhD, Halozyme Therapeutics, San Diego, CA, United States Background and objectives: Edematous fibrosclerotic panniculopathy (cellulite) is clinically characterized by a dimpled appearance of the thighs and buttock of nearly all postpubescent women, and histologically by the constraint of collagenous fibrous septa on adipocyte hypertrophy. Medical treatment options generally lack effectiveness, although surgical subcission to sever the fibrous septa has demonstrated some benefit. We hypothesized that subcutaneous injection of human cathepsin-L (CatL) formulated for transient activity could reproduce the subcission benefit. The objective of this single center double-blind randomized bilateral comparison trial was to determine the safety, tolerability, and pharmacologic effect of CatL injections on the appearance of cellulite.
Conclusions: Under the conditions employed in this study, use of this topical facial skin product daily for sixteen weeks led to measurable improvements in the appearance of facial skin (firmness, elasticity and lines/wrinkles) as well as mechanical properties (skin thickness, collagen) in an aged population of males and females.
Methods: Nonobese (BMI ¼ 30 mg/kg2) adult (18-45 yr) healthy female subjects with cellulite were randomized to receive injections of CatL vs vehicle control on contralateral sides (buttock or thigh). The first study stage was a single dimple dose escalation design, while the second stage treated 5 dimples and incorporated efficacy assessments. Pharmacologic effect was evaluated 7, 14, 28 days and 3 and 6 months after treatment. The primary efficacy endpoint was physician assessment 28 days after treatment, with secondary endpoints of subject self-assessment and objective assessment of 3-dimensional photographic images (Canfield). Results: In the dose-escalation phase, 47 subjects completed the study with no SAEs or dose-limiting toxicities, and all doses were well tolerated. The most common AEs were injection site reactions (pain, bruising, erythema, and edema), which were mild to moderate, self-limiting, and typically resolved within 7-14 days. The most potent dose was studied for pharmacologic effect. In 36 per-protocol evaluable subjects, areas treated with CatL showed a mean improvement of 53% (P \.001) in cellulite appearance at the primary 28 day physician assessment compared to pretreatment, which was significantly greater than vehicle (P ¼ .005). Subject selfassessment showed similar improvement, and the benefit lasted through the final 6 month observation by both physician and subject assessments. Objective assessments of the 3-dimensional photos confirmed these findings. Safety was comparable to the study’s first stage. Conclusions: In this study, CatL treatment reduced the severity of cellulite and was well tolerated. These promising results warrant additional development of CatL to treat cellulite.
Study supported by Kimberly Clarke.
Commercial support: None identified.
AB12
J AM ACAD DERMATOL
MAY 2015
1457
Trauma-focused CBT for a patient with Acne Excoriee: A case report Reena Shah, Barts Health NHS Trust, London, United Kingdom; Alia Ahmed, MBChB, Barts Health NHS Trust, London, United Kingdom; Anthony Bewley, MBChB, Barts Health NHS Trust, London, United Kingdom Introduction: Acne excoriee (AE) is considered to be self-inflicted dermatoses where patients openly report having the compulsive urge to manipulate the acne and picking imagined papules causing the acne to spread. The condition can be chronic, recurring, and often resistant to standard dermatologic and psychiatric treatment. Patients may exhibit two entities: habitual and emotional picking. Habit reversal and relaxation has been shown to be useful for those with AE. However, sometimes there are underlying causes to the picking, such as traumatic memories/flashbacks. In these circumstances, conducting relaxation for the emotional picking can be detrimental as this can exacerbate flashbacks. Methods: A retrospective case review of a patient presenting to a psychodermatology service, specifically to the clinical psychologist. Sessions included patient assessment and trauma-focussed CBT (tf-CBT). Standardized measures were administered pre- and postintervention.
A multicenter clinical evaluation of the performance of fractional radiofrequency technology for improvement of skin texture Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States
Results: A Caucasian female (aged 32) was referred for psychological assessment and treatment after medical treatment was unsuccessful (including phototherapy and topical treatment). She remained on psychiatric medication throughout therapy due to her psychiatric history. The acne and picking started when she was 10 years old. She experienced sexual abuse and verbal aggression from age 5 to 25 years. She had flashbacks of traumatic experiences and her main coping mechanism was to dissociate and pick her acne. One-to-one tf-CBT (16 sessions) was conducted concentrating on the traumatic experiences. Outcome scores indicated a decrease in appearance concern, anxiety and depression and increased quality of life. There was a significant reduction in flashbacks and being able to manage them better and a termination of the picking. Conclusion: Treating patients with AE can be challenging sometimes due to underlying psychological factors perpetuating the picking. It is crucial to gain a high level of trust with patients in order to establish full histories when conducting detailed psychological assessments. It is important to dis/confirm possible underlying causes as some psychological techniques can be detrimental to the patient. Hence a referral to a psychologist and using established psychological interventions can reduce picking and optimise care. To our knowledge, this is the first reported case report of a using a psychological intervention to treat flashbacks to consequently reduce AE.
Introduction and objectives: The visible reduction in the appearance of the acne scars, skin texture irregularities, and or rhytides. Seventy-five centers in North America and 1 hospital in Israel, participated in an IRB approved, multicenter study using a fractional radio frequency (RF) device to treat skin textural irregularities. Materials and methods: Enrollment consisted of both genders (aged 21-60) and all Fitzpatrick skin types and up to 390 patients. Patients were treated with an RF scanner using parallel rows of pins in a rectangular pattern. There are 160 pins per tip covering 150 by 20 micron footprint, 700 microns in height with a 30 degree angle. Scanner deliver of the RF energy allows the applicator to have 4 pins active electrodes while 156 pins are return electrodes. Patients were pretreated with a mild topical anesthetic to allow for additional comfort. One pass of energy pulses is completed over the subjects’ face ensuring that the footprint of each tip pulse is adjacent and not overlapping more than 10%. Posttreatment patients were instructed to use a posttreatment barrier cream and sunblock on subsequent days where sun exposure will be a concern. Treatments are repeated 3 times with an interval of one treatment every 2 weeks on the face. Subjective observations were documented through patient satisfaction and improvement assessment surveys as well as GAI (global assessment improvement scale) photographic assessment was performed by the physicians at the two months post treatment period. Results: At the 1-month follow-up, an average of 73% of patients have observed a visible improvement in their skin with the score increasing to 80% at the 2-month follow-up period. Physicians scored for global assessment were consistent between physicians and remained relatively the same between the 1 month and 2 month follow-up period. Significant improvement has been observed in pigmentation abnormalities but further study is required to establish the device’s efficacy for melasma, solar lentigo, or lentigo senilis. Conclusions: Scanner delivered RF technology can be used with a high degree of confidence to improve the textural appearance of the skin with little downtime and a high degree of patient satisfaction. Consultant and performed research for Venus Concepts.
Commercial support: None identified.
901
AESTHETIC DERMATOLOGY 1742 A 16-week single blind trial evaluating the efficacy of a topical product on skin parameters on older subjects with thin/fragile skin Stephen Schwartz, MS, International Research Services, Inc, Port Chester, NY, United States; Tim McCraw, PhD, Kimberly Clarke Corporation, Roswell, GA, United States; Robert Frumento, Port Chester, NY, United States Background: Thin, fragile skin is a common condition in older adults. The condition can lead to a number of problems, from an aged appearance and a loss of firmness and elasticity to tearing and sensitivity that leads to easy bruising. Mechanistically, collagen and elastin production slows down as we age, making skin drier and less pliable and skin is therefore more prone to wrinkling and scaling, many older adults become upset at the appearance of their skin. Several topical consumer products are available that claim to improve this process, however published data is limited. Methods: This was a 16-week monadic evaluation of one facial skin treatment serum. One test product was used with a standardized supporting moisture product on a panel of forty-eight subjects prequalified as having thin/fragile skin. Instrumental assessments including Cutometer (MPA 580; Courage+Khazaka, Cologne Germany), Ultrasound (DermaScan C; Cortex Technology, Hadsund, Denmark), Clarity Image Analysis (BTBP, San Jose, CA), and SIAscope (MedX; Mississauga, ON, Canada) were performed at visits on weeks 0, 4, 8, 12, and 16. Data from these assessments were utilized for analysis of intended product efficacy. Results: Subject demographics are shown in Table I. The average age of subjects enrolled was 57.62 years. Cutometer results showed early improvements after 4 weeks of use in firmness and elasticity (51.55% and 49.47% improvement, respectively), subjects having these improvements steadily increased throughout the trial. SIAscope collagen data (Table II) showed significant improvements after 12 and 16 weeks of use. Ultrasound data, similarly, showed significant improvements in skin thickness after 12 and 16 weeks of use, echogenicity were numerically improved. Clarity image analysis showed significant improvements in total lines/wrinkles, fine line wrinkles, deep line wrinkles, and the average length and width of wrinkles and in both the crow’s feet region and globally after 16 weeks of product use.
A randomized vehicle-controlled proof-of-concept study of human cathepsin-L injections for the treatment of edematous fibrosclerotic panniculopathy (cellulite) Francisco Perez Atamoros, MD, Centro Dermatol ogico, Miguel Hidalgo, Mexico; Daniel N. Sauder, MD, University of Ottawa, Ottawa, Ontario, Canada; Sonia Barrezueta Chea, MD, Centro Dermatol ogico, Miguel Hidalgo, Mexico; Claudio Castillo Martinez, MD, Centro Dermatol ogico, Miguel Hidalgo, Mexico; Daniel J. Piacquadio, MD, Therapeutics Incorporated, San Diego, CA, United States; David Conway, MS, Halozyme Therapeutics, San Diego, CA, United States; Gilbert A. Keller, PhD, Halozyme Therapeutics, San Diego, CA, United States; Daniel E. Vaughn, PhD, Halozyme Therapeutics, San Diego, CA, United States Background and objectives: Edematous fibrosclerotic panniculopathy (cellulite) is clinically characterized by a dimpled appearance of the thighs and buttock of nearly all postpubescent women, and histologically by the constraint of collagenous fibrous septa on adipocyte hypertrophy. Medical treatment options generally lack effectiveness, although surgical subcission to sever the fibrous septa has demonstrated some benefit. We hypothesized that subcutaneous injection of human cathepsin-L (CatL) formulated for transient activity could reproduce the subcission benefit. The objective of this single center double-blind randomized bilateral comparison trial was to determine the safety, tolerability, and pharmacologic effect of CatL injections on the appearance of cellulite.
Conclusions: Under the conditions employed in this study, use of this topical facial skin product daily for sixteen weeks led to measurable improvements in the appearance of facial skin (firmness, elasticity and lines/wrinkles) as well as mechanical properties (skin thickness, collagen) in an aged population of males and females.
Methods: Nonobese (BMI ¼ 30 mg/kg2) adult (18-45 yr) healthy female subjects with cellulite were randomized to receive injections of CatL vs vehicle control on contralateral sides (buttock or thigh). The first study stage was a single dimple dose escalation design, while the second stage treated 5 dimples and incorporated efficacy assessments. Pharmacologic effect was evaluated 7, 14, 28 days and 3 and 6 months after treatment. The primary efficacy endpoint was physician assessment 28 days after treatment, with secondary endpoints of subject self-assessment and objective assessment of 3-dimensional photographic images (Canfield). Results: In the dose-escalation phase, 47 subjects completed the study with no SAEs or dose-limiting toxicities, and all doses were well tolerated. The most common AEs were injection site reactions (pain, bruising, erythema, and edema), which were mild to moderate, self-limiting, and typically resolved within 7-14 days. The most potent dose was studied for pharmacologic effect. In 36 per-protocol evaluable subjects, areas treated with CatL showed a mean improvement of 53% (P \.001) in cellulite appearance at the primary 28 day physician assessment compared to pretreatment, which was significantly greater than vehicle (P ¼ .005). Subject selfassessment showed similar improvement, and the benefit lasted through the final 6 month observation by both physician and subject assessments. Objective assessments of the 3-dimensional photos confirmed these findings. Safety was comparable to the study’s first stage. Conclusions: In this study, CatL treatment reduced the severity of cellulite and was well tolerated. These promising results warrant additional development of CatL to treat cellulite.
Study supported by Kimberly Clarke.
Commercial support: None identified.
AB12
J AM ACAD DERMATOL
MAY 2015