Journal of Cosmetic and Laser Therapy
ISSN: 1476-4172 (Print) 1476-4180 (Online) Journal homepage: http://www.tandfonline.com/loi/ijcl20
Non-invasive cryolipolysis to reduce subcutaneous fat in the arms Sang Jun Lee, Hee Won Jang, Hyunjoo Kim, Dong Hye Suh & Hwa Jung Ryu To cite this article: Sang Jun Lee, Hee Won Jang, Hyunjoo Kim, Dong Hye Suh & Hwa Jung Ryu (2016): Non-invasive cryolipolysis to reduce subcutaneous fat in the arms, Journal of Cosmetic and Laser Therapy, DOI: 10.3109/14764172.2015.1114644 To link to this article: http://dx.doi.org/10.3109/14764172.2015.1114644
Accepted author version posted online: 06 Jan 2016.
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Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ijcl20 Download by: [Emory University]
Date: 14 February 2016, At: 08:18
Just Accepted by Journal of Cosmetic and Laser Therapy
Non-invasive cryolipolysis to reduce subcutaneous fat in the arms Sang Jun Lee, Hee Won Jang, Hyunjoo Kim, Dong Hye Suh, Hwa Jung Ryu Doi: 10.3109/14764172.2015.1114644
Downloaded by [Emory University] at 08:18 14 February 2016
ABSTRACT Background: Cryolipolysis received U.S. Food and Drug Administration clearance for reducing fat from the flanks, abdomen, and thighs. The upper arms are an off-label indication for cryolipolysis, and outcome data on reducing fat from the arms using a cryolipolytic device has rarely been published. Objective: This pilot study evaluated cryolipolysis to reduce upper arm fat. Methods & Materials: A flat vacuum applicator was used to treat seven subjects in a single-side study. The patients underwent one cycle of upper arm cryolipolysis treatment, and the contralateral arm served as a control. Follow-up was conducted at 8 weeks. Equalization treatments were delivered subsequently to the opposite arm. Efficacy was evaluated by ultrasound imaging, physician’s assessment, and patient satisfaction. Side effects and adverse events were monitored. Results: Ultrasound measurements showed a decrease in the fat layer at 83.3% of the 12 measured sites. The mean reduction in fat layer thickness was 15.3%, corresponding to 2.03 mm. A significant difference was detected between baseline and 8-week assessments (p = 0.001). Conclusion: One treatment using a flat vacuum cryolipolysis applicator was safe and effective to reduce arm fat.
© 2015 Taylor & Francis. This provisional PDF corresponds to the article as it appeared upon acceptance. Fully formatted PDF and full text (HTML) versions will be made available soon. DISCLAIMER: The ideas and opinions expressed in the journal’s Just Accepted articles do not necessarily reflect those of Taylor & Francis (the Publisher), the Editors or the journal. The Publisher does not assume any responsibility for any injury and/or damage to persons or property arising from or related to any use of the material contained in these articles. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosages, the method and duration of administration, and contraindications. It is the responsibility of the treating physician or other health care professional, relying on his or her independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Just Accepted articles have undergone full scientific review but none of the additional editorial preparation, such as copyediting, typesetting, and proofreading, as have articles published in the traditional manner. There may, therefore, be errors in Just Accepted articles that will be corrected in the final print and final online version of the article. Any use of the Just Accepted articles is subject to the express understanding that the papers have not yet gone through the full quality control process prior to publication.
Non-invasive cryolipolysis to reduce subcutaneous fat in the arms
Sang Jun Lee1, Hee Won Jang2, Hyunjoo Kim1, Dong Hye Suh1, Hwa Jung Ryu2 1
Arumdaun Nara Dermatologic Clinic, Seoul, Korea, 2Department of Dermatology, Korea
University College of Medicine, Seoul, Korea
Corresponding author: Hwa Jung Ryu, M.D., Ph.D., E-mail: [email protected], Department of Dermatology, Korea University Ansan Hospital, College of Medicine, Korea University, 516 Gojan-dong, Ansan, Kyeonggi-do, Seoul 425-707, Korea Downloaded by [Emory University] at 08:18 14 February 2016
ABSTRACT Background: Cryolipolysis received U.S. Food and Drug Administration clearance for reducing fat from the flanks, abdomen, and thighs. The upper arms are an off-label indication for cryolipolysis, and outcome data on reducing fat from the arms using a cryolipolytic device has rarely been published. Objective: This pilot study evaluated cryolipolysis to reduce upper arm fat. Methods & Materials: A flat vacuum applicator was used to treat seven subjects in a single-side study. The patients underwent one cycle of upper arm cryolipolysis treatment, and the contralateral arm served as a control. Follow-up was conducted at 8 weeks. Equalization treatments were delivered subsequently to the opposite arm. Efficacy was evaluated by ultrasound imaging, physician’s assessment, and patient satisfaction. Side effects and adverse events were monitored. Results: Ultrasound measurements showed a decrease in the fat layer at 83.3% of the 12 measured sites. The mean reduction in fat layer thickness was 15.3%, corresponding to 2.03 mm. A significant difference was detected between baseline and 8-week assessments (p = 0.001). Conclusion: One treatment using a flat vacuum cryolipolysis applicator was safe and effective to reduce arm fat.
Keywords: Cryolipolysis, ulnar nerve
Received 19 May 2015, Accepted 26 June 2015
1
INTRODUCTION Many people want to be thin, based on the growing interest in beauty and health. Although liposuction is the most popular surgical treatment to reduce fat, patients are concerned about severe complications, such as pulmonary embolism, leading to a lethal outcome.1 Thus, non-invasive body contouring procedures have grown rapidly in the aesthetic cosmetic industry. A cryolipolytic device (CoolSculpting system, Zeltiq Aesthetics, Pleasanton, CA, USA) received U.S. Food and Drug Administration clearance to
Downloaded by [Emory University] at 08:18 14 February 2016
decrease flank fat in 2010, for reducing abdominal fat in 2012, and for reducing inner thigh fat in April 2014.2 Some authors have reported that cryolipolysis on the abdomen, flanks, and thighs is safe and effective.3-5 In particular, Korean women desire slim arms and demand a reduction in subcutaneous fat of the arms. Because some people are reluctant to undergo an invasive procedure, non-invasive cryolipolysis of the upper arms has been used off-label. However, the safety and efficacy of this procedure have rarely been demonstrated. Various applicators are commercially available and have been used to decrease abdominal and flank fat. As these applicators have a curved cup, it is appropriate for use on the abdomen and flank but unsuitable for a long flat surface, such as the inner thigh and upper arm. The safety and efficacy of the flat cup vacuum applicator for the inner thigh have been reported.5 In this study, we determined the efficacy and safety of reducing upper arm fat noninvasively using a cryolipolytic device with a flat cup vacuum applicator.
2
MATERIALS AND METHODS Subjects who visited the Arumdaun Nara Dermatologic Clinic from January to June 2014 were included. We recruited females (age, 20–65 years) with discrete fat bulges in the upper arms and body weight ≤ 70 kg. The patients were requested to not change their dietary habits or lifestyle and that their body weight should not change more than 5 kg. Potential subjects were excluded if they had received liposuction or another surgical procedure on the upper arms, had a history of subcutaneous
Downloaded by [Emory University] at 08:18 14 February 2016
infections in the area within the past 4 weeks; had a psychiatric problem, such as body dysmorphism, or were pregnant or lactating. Potential side effects, including erythema, bruising, and neurological complications were explained to the patients prior to treatment. Informed consent was obtained from all patients. The patients underwent cryolipolysis of a random arm and the contralateral arm was used as a control. All patients were treated with the same preprogrammed parameters: 60 min duration at a cooling intensity factor of 41.6 (−72.9 mW/cm2). The procedure was repeated on the contralateral side after 2 months of close observation of the initially treated area. A physician assessed the treatment using a clinical digital photograph, and ultrasound measurements were conducted at baseline and 8 weeks after the procedure. Digital photographic images were obtained under controlled conditions using the same light source, room, and camera. The clinical photographs were reviewed by blinded, independent physician reviewers. The outcomes were divided into: “excellent”, “good”, “fair”, and “poor”. A
3
model SonoAce 6000 ultrasound device (Medison, Seoul, Korea) with a 7.5 MHz high-resolution linear transducer was used to assess the fat layer. A transparent piece of vinyl was created for the treated side of each subject to align the ultrasound measurement sites to anatomical features (e.g., nevi and scars). The baseline ultrasound measurement of fat layer thickness was conducted on the proximal and distal upper arm, and fat reduction was measured in the same area after 8 weeks. We surveyed adverse events and side effects during the study, and the
Downloaded by [Emory University] at 08:18 14 February 2016
patient’s level of satisfaction was self-evaluated according to the scale of “excellent”, “good”, and “unsatisfied”. The principles of the 1975 Declaration of Helsinki were followed. All statistical analyses were conducted using PASW ver. 18.0 software (IBM, Armonk, NY, USA). Descriptive statistics are presented as numbers and percentages of patients or as means. The paired t-test was used to detect differences between baseline ultrasound measurements and those taken 2 months after treatment. A p < 0.05 was considered significant. RESULTS Seven patients were enrolled but one subject (no. 2) was lost to follow-up. All patients were females with a mean age of 27.17 years (range, 21–33 years). The Fitzpatrick skin types were II–IV. The results are summarized in Table 1. The follow-up period was 8 weeks. Initial body weight was 49.2– 60.7 kg, and mean body weight was 53.37 kg. No subject was excluded due to a change in weight > 5 kg, as the mean change in body weight was +0.27 kg, and no difference was detected between the baseline and 8 week body weights (p = 0.621).
4
Three subjects underwent cryolipolysis on the right arm and the others underwent the procedure on the left arm. The physician’s assessments using clinical photographs (Fig. 1) were classified as excellent in one (16.7%), good in four (66.7%), and fair in one (16.7%) subject. The ultrasound measurements 8 weeks after procedure revealed a mean fat reduction of 2.03 mm (range, 0–5.0 mm) (p = 0.001; Fig. 2). The self-evaluated result of five (83.3%) patients was satisfactory, including two (33.3%) patients with excellent and three (50%) with good results, as
Downloaded by [Emory University] at 08:18 14 February 2016
well as unsatisfactory for the remaining one (16.7%) patient. The side effects and adverse events after cryolipolysis were transient. Three patients complained of hand numbness during the procedure. One showed a claw hand, which resolved after an hour of massage (Fig. 3). All subjects showed mild erythema, swelling, and bruising after the procedure, and two patients complained of mild pain after the procedure. These side effects lasted for a maximum of 2 weeks and did not warrant treatment. DISCUSSION The principles of non-surgical fat reduction procedures are fat cell necrosis or apoptosis. Cryolipolysis, low level lasers, radiofrequency, and high intensity focused ultrasound are included as non-surgical fat reduction techniques.6 Many studies have been published on cryolipolysis in animals and humans. Manstein et al.7 described and defined “selective cryolipolysis,” in a pig model as cold-induced destruction of fatty tissue that does not affect adjacent tissues. Additional studies support that cryolipolysis reduces fat cells selectively without injuring surrounding tissues.8
5
Previous ultrasound measurements of inner thigh fat tissue after cryolipolysis were 2.8–3.3 mm fat reduction 16 weeks after the procedure.2, 5 One study reported a 2.6 mm reduction lower abdominal fat by ultrasound.9 However, few reports are available on the reduction of upper arm fat after cryolipolysis. We achieved a 2.03 mm (15.3%) fat reduction in the upper arm after one cryolipolysis cycle. Boey et al.9 suggested that manual massage improves clinical outcomes from cryolipolysis. Manual massage after cryolipolysis of the arms may also
Downloaded by [Emory University] at 08:18 14 February 2016
reduce discomfort, such as numbness, after the procedure. Bernstein et al.3 reported that multiple cycles of cryolipolysis for the flank were effective and safe. Multiple treatment cycles for the arms may be helpful for patients who are unsatisfied with the results of one treatment. Clinical studies about cryolipolysis show various side effects, including temporary erythema, bruising, and transient numbness.2-4, 9, 10 These side effects usually resolve within 14 days after treatment8, as in our study. As with previous studies, most patients developed mild erythema and bruising after cryolipolysis of the arms. In our study, the patients were not in pain during the procedure, but some complained of minor pain after treatment. Some patients developed numbness during or after the procedure. A nerve biopsy assessment after cryolipolysis showed that cryolipolysis is associated with reversible short-term changes in of peripheral sensory nerve function.10 Zelickson et al.2 evaluated the duration of side effects after inner thigh cryolipolysis. The longest time to full recovery from numbness was 132 days. If patients develop arm or hand numbness during or after the procedure, massage may be helpful to relax the patient and resolve the symptoms faster.
6
We experienced transient claw hand after cryolipolysis of the upper arm, which resolved within one hour after massage, and did not warrant treatment. No reports are available on motor nerve malfunction after cryolipolysis. However, close observation of the patient’s response is needed, as the courses of major nerves are superficial in the arms, unlike the abdomen, flank, and thighs. Physicians should avoid conducting cryolipolysis near the elbow because the ulnar nerve runs very superficially near the medial condyle of the humerus. In addition, subjects with too little fat on the upper
Downloaded by [Emory University] at 08:18 14 February 2016
arm should not be treated with cryolipolysis due to a risk of nerve injury. In conclusion, cryolipolytic fat reduction of the arms was effective and safe in this pilot study. However, in physicians should carefully perform upper arm, cryolipolysis because of the superficial course of the ulnar nerve near the elbow. A further large prospective clinical study is needed. DISCLOSURE OF INTERESTS: The authors report no conflicts of interest.
7
References 1. Sattler G, Eichner S. Complications of liposuction. Hautarzt 2013;64:171179. 2. Zelickson BD, Burns AJ, Kilmer SL. Cryolipolysis for safe and effective inner thigh fat reduction. Lasers Surg Med 2015;47(2):120-127. 3. Bernstein EF, Bloom JD, Basilavecchio LD, Plugis JM. Non-invasive fat reduction of the flanks using a new cryolipolysis applicator and overlapping, two-cycle treatments. Lasers Surg Med 2014;46(10):731-735.
Downloaded by [Emory University] at 08:18 14 February 2016
4. Kim J, Kim DH, Ryu HJ. Clinical effectiveness of non-invasive selective cryolipolysis. J Cosmet Laser Ther 2014;16:209-213. 5. Boey GE, Wasilenchuk JL. Fat reduction in the inner thigh using a prototype cryolipolysis applicator. Dermatol Surg 2014;40:1004-1009. 6. Krueger N, Mai SV, Luebberding S, Sadick NS. Cryolipolysis for noninvasive body contouring: Clinical efficacy and patient satisfaction. Clin Cosmet Investig Dermatol 2014;7:201-205. 7. Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. Selective cryolysis: A novel method of non-invasive fat removal. Lasers Surg Med 2008;40:595-604. 8. Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Rhoades RW, et al. Cryolipolysis for noninvasive fat cell destruction: Initial results from a pig model. Dermatol Surg 2009;35:1462-1470. 9. Boey GE, Wasilenchuk JL. Enhanced clinical outcome with manual massage following cryolipolysis treatment: A 4-month study of safety and efficacy. Lasers Surg Med 2014;46:20-26.
8
10. Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves.
Downloaded by [Emory University] at 08:18 14 February 2016
Aesthetic Plast Surg 2009;33:482-488.
9
Figure legends Figure 1. Clinical digital photographs of a representative patient. (A)
Downloaded by [Emory University] at 08:18 14 February 2016
Baseline. (B) After 8 weeks.
10
Downloaded by [Emory University] at 08:18 14 February 2016
Figure 2. Ultrasound images of the fat layer. (A) Baseline. (B) After 8 weeks.
11
Figure 3. Claw hand of a patient immediately after cryolipolysis, which
Downloaded by [Emory University] at 08:18 14 February 2016
resolved after 1 hour of massage.
12
Table Legend Table 1. Demographic characteristics and ultrasound measured values of the six patients
Subject no.
Sex
Age
Treated area
Body weight (kg) Baseline
F F F F F F
29 21 33 26 27 27
Rt Lt Lt Rt Rt Lt
52 54.6 52.2 60.7 51.5 49.2
Downloaded by [Emory University] at 08:18 14 February 2016
1 3 4 5 6 7
After 8 weeks 50.7 55.3 53 60.3 54.5 48
Fat layer thickness of treated area (distal/proximal, mm) After 8 Baseline weeks 13.7 / 14.2 10.3 / 11.9 15.8 / 18.1 12.7 / 16.9 9.7 / 11.5 7.4 / 10.4 12.3 /14.4 12.3 / 14.2 10.7 / 11.5 10.7 / 9.8 13.5 / 13.5 9.4 / 8.5
13
ISSN: 1476-4172 (Print) 1476-4180 (Online) Journal homepage: http://www.tandfonline.com/loi/ijcl20
Non-invasive cryolipolysis to reduce subcutaneous fat in the arms Sang Jun Lee, Hee Won Jang, Hyunjoo Kim, Dong Hye Suh & Hwa Jung Ryu To cite this article: Sang Jun Lee, Hee Won Jang, Hyunjoo Kim, Dong Hye Suh & Hwa Jung Ryu (2016): Non-invasive cryolipolysis to reduce subcutaneous fat in the arms, Journal of Cosmetic and Laser Therapy, DOI: 10.3109/14764172.2015.1114644 To link to this article: http://dx.doi.org/10.3109/14764172.2015.1114644
Accepted author version posted online: 06 Jan 2016.
Submit your article to this journal
Article views: 11
View related articles
View Crossmark data
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ijcl20 Download by: [Emory University]
Date: 14 February 2016, At: 08:18
Just Accepted by Journal of Cosmetic and Laser Therapy
Non-invasive cryolipolysis to reduce subcutaneous fat in the arms Sang Jun Lee, Hee Won Jang, Hyunjoo Kim, Dong Hye Suh, Hwa Jung Ryu Doi: 10.3109/14764172.2015.1114644
Downloaded by [Emory University] at 08:18 14 February 2016
ABSTRACT Background: Cryolipolysis received U.S. Food and Drug Administration clearance for reducing fat from the flanks, abdomen, and thighs. The upper arms are an off-label indication for cryolipolysis, and outcome data on reducing fat from the arms using a cryolipolytic device has rarely been published. Objective: This pilot study evaluated cryolipolysis to reduce upper arm fat. Methods & Materials: A flat vacuum applicator was used to treat seven subjects in a single-side study. The patients underwent one cycle of upper arm cryolipolysis treatment, and the contralateral arm served as a control. Follow-up was conducted at 8 weeks. Equalization treatments were delivered subsequently to the opposite arm. Efficacy was evaluated by ultrasound imaging, physician’s assessment, and patient satisfaction. Side effects and adverse events were monitored. Results: Ultrasound measurements showed a decrease in the fat layer at 83.3% of the 12 measured sites. The mean reduction in fat layer thickness was 15.3%, corresponding to 2.03 mm. A significant difference was detected between baseline and 8-week assessments (p = 0.001). Conclusion: One treatment using a flat vacuum cryolipolysis applicator was safe and effective to reduce arm fat.
© 2015 Taylor & Francis. This provisional PDF corresponds to the article as it appeared upon acceptance. Fully formatted PDF and full text (HTML) versions will be made available soon. DISCLAIMER: The ideas and opinions expressed in the journal’s Just Accepted articles do not necessarily reflect those of Taylor & Francis (the Publisher), the Editors or the journal. The Publisher does not assume any responsibility for any injury and/or damage to persons or property arising from or related to any use of the material contained in these articles. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosages, the method and duration of administration, and contraindications. It is the responsibility of the treating physician or other health care professional, relying on his or her independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Just Accepted articles have undergone full scientific review but none of the additional editorial preparation, such as copyediting, typesetting, and proofreading, as have articles published in the traditional manner. There may, therefore, be errors in Just Accepted articles that will be corrected in the final print and final online version of the article. Any use of the Just Accepted articles is subject to the express understanding that the papers have not yet gone through the full quality control process prior to publication.
Non-invasive cryolipolysis to reduce subcutaneous fat in the arms
Sang Jun Lee1, Hee Won Jang2, Hyunjoo Kim1, Dong Hye Suh1, Hwa Jung Ryu2 1
Arumdaun Nara Dermatologic Clinic, Seoul, Korea, 2Department of Dermatology, Korea
University College of Medicine, Seoul, Korea
Corresponding author: Hwa Jung Ryu, M.D., Ph.D., E-mail: [email protected], Department of Dermatology, Korea University Ansan Hospital, College of Medicine, Korea University, 516 Gojan-dong, Ansan, Kyeonggi-do, Seoul 425-707, Korea Downloaded by [Emory University] at 08:18 14 February 2016
ABSTRACT Background: Cryolipolysis received U.S. Food and Drug Administration clearance for reducing fat from the flanks, abdomen, and thighs. The upper arms are an off-label indication for cryolipolysis, and outcome data on reducing fat from the arms using a cryolipolytic device has rarely been published. Objective: This pilot study evaluated cryolipolysis to reduce upper arm fat. Methods & Materials: A flat vacuum applicator was used to treat seven subjects in a single-side study. The patients underwent one cycle of upper arm cryolipolysis treatment, and the contralateral arm served as a control. Follow-up was conducted at 8 weeks. Equalization treatments were delivered subsequently to the opposite arm. Efficacy was evaluated by ultrasound imaging, physician’s assessment, and patient satisfaction. Side effects and adverse events were monitored. Results: Ultrasound measurements showed a decrease in the fat layer at 83.3% of the 12 measured sites. The mean reduction in fat layer thickness was 15.3%, corresponding to 2.03 mm. A significant difference was detected between baseline and 8-week assessments (p = 0.001). Conclusion: One treatment using a flat vacuum cryolipolysis applicator was safe and effective to reduce arm fat.
Keywords: Cryolipolysis, ulnar nerve
Received 19 May 2015, Accepted 26 June 2015
1
INTRODUCTION Many people want to be thin, based on the growing interest in beauty and health. Although liposuction is the most popular surgical treatment to reduce fat, patients are concerned about severe complications, such as pulmonary embolism, leading to a lethal outcome.1 Thus, non-invasive body contouring procedures have grown rapidly in the aesthetic cosmetic industry. A cryolipolytic device (CoolSculpting system, Zeltiq Aesthetics, Pleasanton, CA, USA) received U.S. Food and Drug Administration clearance to
Downloaded by [Emory University] at 08:18 14 February 2016
decrease flank fat in 2010, for reducing abdominal fat in 2012, and for reducing inner thigh fat in April 2014.2 Some authors have reported that cryolipolysis on the abdomen, flanks, and thighs is safe and effective.3-5 In particular, Korean women desire slim arms and demand a reduction in subcutaneous fat of the arms. Because some people are reluctant to undergo an invasive procedure, non-invasive cryolipolysis of the upper arms has been used off-label. However, the safety and efficacy of this procedure have rarely been demonstrated. Various applicators are commercially available and have been used to decrease abdominal and flank fat. As these applicators have a curved cup, it is appropriate for use on the abdomen and flank but unsuitable for a long flat surface, such as the inner thigh and upper arm. The safety and efficacy of the flat cup vacuum applicator for the inner thigh have been reported.5 In this study, we determined the efficacy and safety of reducing upper arm fat noninvasively using a cryolipolytic device with a flat cup vacuum applicator.
2
MATERIALS AND METHODS Subjects who visited the Arumdaun Nara Dermatologic Clinic from January to June 2014 were included. We recruited females (age, 20–65 years) with discrete fat bulges in the upper arms and body weight ≤ 70 kg. The patients were requested to not change their dietary habits or lifestyle and that their body weight should not change more than 5 kg. Potential subjects were excluded if they had received liposuction or another surgical procedure on the upper arms, had a history of subcutaneous
Downloaded by [Emory University] at 08:18 14 February 2016
infections in the area within the past 4 weeks; had a psychiatric problem, such as body dysmorphism, or were pregnant or lactating. Potential side effects, including erythema, bruising, and neurological complications were explained to the patients prior to treatment. Informed consent was obtained from all patients. The patients underwent cryolipolysis of a random arm and the contralateral arm was used as a control. All patients were treated with the same preprogrammed parameters: 60 min duration at a cooling intensity factor of 41.6 (−72.9 mW/cm2). The procedure was repeated on the contralateral side after 2 months of close observation of the initially treated area. A physician assessed the treatment using a clinical digital photograph, and ultrasound measurements were conducted at baseline and 8 weeks after the procedure. Digital photographic images were obtained under controlled conditions using the same light source, room, and camera. The clinical photographs were reviewed by blinded, independent physician reviewers. The outcomes were divided into: “excellent”, “good”, “fair”, and “poor”. A
3
model SonoAce 6000 ultrasound device (Medison, Seoul, Korea) with a 7.5 MHz high-resolution linear transducer was used to assess the fat layer. A transparent piece of vinyl was created for the treated side of each subject to align the ultrasound measurement sites to anatomical features (e.g., nevi and scars). The baseline ultrasound measurement of fat layer thickness was conducted on the proximal and distal upper arm, and fat reduction was measured in the same area after 8 weeks. We surveyed adverse events and side effects during the study, and the
Downloaded by [Emory University] at 08:18 14 February 2016
patient’s level of satisfaction was self-evaluated according to the scale of “excellent”, “good”, and “unsatisfied”. The principles of the 1975 Declaration of Helsinki were followed. All statistical analyses were conducted using PASW ver. 18.0 software (IBM, Armonk, NY, USA). Descriptive statistics are presented as numbers and percentages of patients or as means. The paired t-test was used to detect differences between baseline ultrasound measurements and those taken 2 months after treatment. A p < 0.05 was considered significant. RESULTS Seven patients were enrolled but one subject (no. 2) was lost to follow-up. All patients were females with a mean age of 27.17 years (range, 21–33 years). The Fitzpatrick skin types were II–IV. The results are summarized in Table 1. The follow-up period was 8 weeks. Initial body weight was 49.2– 60.7 kg, and mean body weight was 53.37 kg. No subject was excluded due to a change in weight > 5 kg, as the mean change in body weight was +0.27 kg, and no difference was detected between the baseline and 8 week body weights (p = 0.621).
4
Three subjects underwent cryolipolysis on the right arm and the others underwent the procedure on the left arm. The physician’s assessments using clinical photographs (Fig. 1) were classified as excellent in one (16.7%), good in four (66.7%), and fair in one (16.7%) subject. The ultrasound measurements 8 weeks after procedure revealed a mean fat reduction of 2.03 mm (range, 0–5.0 mm) (p = 0.001; Fig. 2). The self-evaluated result of five (83.3%) patients was satisfactory, including two (33.3%) patients with excellent and three (50%) with good results, as
Downloaded by [Emory University] at 08:18 14 February 2016
well as unsatisfactory for the remaining one (16.7%) patient. The side effects and adverse events after cryolipolysis were transient. Three patients complained of hand numbness during the procedure. One showed a claw hand, which resolved after an hour of massage (Fig. 3). All subjects showed mild erythema, swelling, and bruising after the procedure, and two patients complained of mild pain after the procedure. These side effects lasted for a maximum of 2 weeks and did not warrant treatment. DISCUSSION The principles of non-surgical fat reduction procedures are fat cell necrosis or apoptosis. Cryolipolysis, low level lasers, radiofrequency, and high intensity focused ultrasound are included as non-surgical fat reduction techniques.6 Many studies have been published on cryolipolysis in animals and humans. Manstein et al.7 described and defined “selective cryolipolysis,” in a pig model as cold-induced destruction of fatty tissue that does not affect adjacent tissues. Additional studies support that cryolipolysis reduces fat cells selectively without injuring surrounding tissues.8
5
Previous ultrasound measurements of inner thigh fat tissue after cryolipolysis were 2.8–3.3 mm fat reduction 16 weeks after the procedure.2, 5 One study reported a 2.6 mm reduction lower abdominal fat by ultrasound.9 However, few reports are available on the reduction of upper arm fat after cryolipolysis. We achieved a 2.03 mm (15.3%) fat reduction in the upper arm after one cryolipolysis cycle. Boey et al.9 suggested that manual massage improves clinical outcomes from cryolipolysis. Manual massage after cryolipolysis of the arms may also
Downloaded by [Emory University] at 08:18 14 February 2016
reduce discomfort, such as numbness, after the procedure. Bernstein et al.3 reported that multiple cycles of cryolipolysis for the flank were effective and safe. Multiple treatment cycles for the arms may be helpful for patients who are unsatisfied with the results of one treatment. Clinical studies about cryolipolysis show various side effects, including temporary erythema, bruising, and transient numbness.2-4, 9, 10 These side effects usually resolve within 14 days after treatment8, as in our study. As with previous studies, most patients developed mild erythema and bruising after cryolipolysis of the arms. In our study, the patients were not in pain during the procedure, but some complained of minor pain after treatment. Some patients developed numbness during or after the procedure. A nerve biopsy assessment after cryolipolysis showed that cryolipolysis is associated with reversible short-term changes in of peripheral sensory nerve function.10 Zelickson et al.2 evaluated the duration of side effects after inner thigh cryolipolysis. The longest time to full recovery from numbness was 132 days. If patients develop arm or hand numbness during or after the procedure, massage may be helpful to relax the patient and resolve the symptoms faster.
6
We experienced transient claw hand after cryolipolysis of the upper arm, which resolved within one hour after massage, and did not warrant treatment. No reports are available on motor nerve malfunction after cryolipolysis. However, close observation of the patient’s response is needed, as the courses of major nerves are superficial in the arms, unlike the abdomen, flank, and thighs. Physicians should avoid conducting cryolipolysis near the elbow because the ulnar nerve runs very superficially near the medial condyle of the humerus. In addition, subjects with too little fat on the upper
Downloaded by [Emory University] at 08:18 14 February 2016
arm should not be treated with cryolipolysis due to a risk of nerve injury. In conclusion, cryolipolytic fat reduction of the arms was effective and safe in this pilot study. However, in physicians should carefully perform upper arm, cryolipolysis because of the superficial course of the ulnar nerve near the elbow. A further large prospective clinical study is needed. DISCLOSURE OF INTERESTS: The authors report no conflicts of interest.
7
References 1. Sattler G, Eichner S. Complications of liposuction. Hautarzt 2013;64:171179. 2. Zelickson BD, Burns AJ, Kilmer SL. Cryolipolysis for safe and effective inner thigh fat reduction. Lasers Surg Med 2015;47(2):120-127. 3. Bernstein EF, Bloom JD, Basilavecchio LD, Plugis JM. Non-invasive fat reduction of the flanks using a new cryolipolysis applicator and overlapping, two-cycle treatments. Lasers Surg Med 2014;46(10):731-735.
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4. Kim J, Kim DH, Ryu HJ. Clinical effectiveness of non-invasive selective cryolipolysis. J Cosmet Laser Ther 2014;16:209-213. 5. Boey GE, Wasilenchuk JL. Fat reduction in the inner thigh using a prototype cryolipolysis applicator. Dermatol Surg 2014;40:1004-1009. 6. Krueger N, Mai SV, Luebberding S, Sadick NS. Cryolipolysis for noninvasive body contouring: Clinical efficacy and patient satisfaction. Clin Cosmet Investig Dermatol 2014;7:201-205. 7. Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. Selective cryolysis: A novel method of non-invasive fat removal. Lasers Surg Med 2008;40:595-604. 8. Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Rhoades RW, et al. Cryolipolysis for noninvasive fat cell destruction: Initial results from a pig model. Dermatol Surg 2009;35:1462-1470. 9. Boey GE, Wasilenchuk JL. Enhanced clinical outcome with manual massage following cryolipolysis treatment: A 4-month study of safety and efficacy. Lasers Surg Med 2014;46:20-26.
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10. Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves.
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Aesthetic Plast Surg 2009;33:482-488.
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Figure legends Figure 1. Clinical digital photographs of a representative patient. (A)
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Baseline. (B) After 8 weeks.
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Figure 2. Ultrasound images of the fat layer. (A) Baseline. (B) After 8 weeks.
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Figure 3. Claw hand of a patient immediately after cryolipolysis, which
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resolved after 1 hour of massage.
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Table Legend Table 1. Demographic characteristics and ultrasound measured values of the six patients
Subject no.
Sex
Age
Treated area
Body weight (kg) Baseline
F F F F F F
29 21 33 26 27 27
Rt Lt Lt Rt Rt Lt
52 54.6 52.2 60.7 51.5 49.2
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1 3 4 5 6 7
After 8 weeks 50.7 55.3 53 60.3 54.5 48
Fat layer thickness of treated area (distal/proximal, mm) After 8 Baseline weeks 13.7 / 14.2 10.3 / 11.9 15.8 / 18.1 12.7 / 16.9 9.7 / 11.5 7.4 / 10.4 12.3 /14.4 12.3 / 14.2 10.7 / 11.5 10.7 / 9.8 13.5 / 13.5 9.4 / 8.5
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