cold - induced panniculitis , with subsequent atrophy is a well - known phenomenon in both children and adults [ 13 ] . based upon observations of fat susceptibility to cold injury and a case report of popsicle panniculitis
, researchers studied and developed controlled cryolipolysis ; the controlled application of cooling to non - invasively reduce subcutaneous fat .
that study demonstrated fat reduction via examination by ultrasound and histopathologic evaluation ; safety data were collected in this animal model by demonstrating no skin injury and a lack of change in serum lipid levels following treatment . since then , there have been follow - up porcine   and human clinical studies showing safe and effective cryolipolysis in a number of treatment areas including the abdomen , flanks , and thighs [ 713 ] .
the safety of cryolipolysis treatments has also been demonstrated in clinical studies of cryolipolysis where serum lipid levels and liver function tests were performed , as well as peripheral nerve studies , all demonstrating no abnormalities following treatment .
food and drug administration ( fda ) clearance for fat reduction of the flanks in 2010 , for abdominal fat reduction in 2012 , and for fat reduction of the thighs in 2014 .
studies have also demonstrated safety and effectiveness for treatment of undesirable fat in the back , arms , and chest [ 1619 ] .
long - term persistence of fat reduction has been demonstrated in subjects treated to a single flank , to control for fluctuations in weight , for up to five years following a single treatment session .
since flanks are perhaps the most commonly treated of all cryolipolysis sites , this study was intended to investigate improvements to flank treatment efficacy using a new cryolipolysis handpiece .
previously , a moderately - contoured applicator ( coolcurve , ez app 6.2 , zeltiq aesthetics , inc . ,
pleasanton , ca ) was used for flank treatments . a new applicator with a sharply contoured vacuum cup and curved cooling panels ( coolcurve+ , zeltiq aesthetics , inc . )
design changes were intended to provide improved patient fit and tissue draw for sharply contoured treatment sites such as flanks .
this study investigates the safety and efficacy of two overlapping treatment cycles to the flanks using a sharply - contoured cryolipolysis vacuum applicator .
this institutional review board ( irb)-approved clinical study investigated the safety and efficacy of treatment with two cycles per flank , administered in two separate treatment sessions utilizing a new , sharply - contoured vacuum applicator ( coolcurve+ applicator , zeltiq aesthetics , inc . ) in treating unwanted flank fat on 20 treatment sites in 10 subjects .
two cycles were delivered to each flank in a bilateral treatment protocol in a single office visit .
investigator measurements show the previous generation contoured applicator ( coolcurve ) and the applicator evaluated in this study ( coolcurve+ ) treat approximately the same volume of tissue .
while the cooling plate sizes are similar , the new applicator has a curved edge to better fit a patient 's contour .
the new applicator cup has approximately 1.6  cm longer ears ( lateral edges ) and an approximately 6 increased angle to better accommodate contoured treatment areas , such as flanks .
subjects ranged from 33 to 56 years of age , averaging 42.2 years old and were all females .
subjects selected for the study had clearly visible fat on their flanks , and a body mass index ( bmi ) of up to 30 .
bmi was measured after measuring a subject 's height and weight ; these values were entered into an online bmi calculator ( bmi calculator , tim o 's studios , llc , austin , tx ) . for the duration of the study
, subjects were instructed to avoid implementing major diet or lifestyle changes in order to maintain their weight within 5  lbs of baseline measurement .
cryolipolysis treatment was delivered at a cooling intensity factor 41.6 , corresponding to an average energy extraction rate of 72.9  mw / cm .
the flank fat was drawn by moderate vacuum suction between cooled plates in the applicator . at the conclusion of each 60  minute cycle ,
the treatment area was vigorously massaged by hand for 5  minutes ; then the remaining flank fat was treated using the same protocol .
thus , 4 cycles ( 2 per flank ) were administered on the treatment day , treating both flanks with 2 cycles each , overlapping 50% .
treatment efficacy was determined by blinded - expert analysis of clinical photographs viewed in pairs . at the baseline pre - treatment visit and 12-week follow - up visits
, photographs were acquired using a standardized photography set - up using a professional digital camera with a 60  mm lens ( d300 camera , nikon inc . ,
melville , ny ) with floor - standing , external , bilaterally - symmetrical strobe lighting , with 1,000  w heads and soft - boxes ( dynalite , inc . ,
subjects were photographed with their feet separated at a fixed distance using a foot positioning guide and arms in a fixed , standard position . at the completion of the study ,
clinical photographs were reviewed by four blinded , independent physicians to choose which photographs were pre- versus post - treatment photographs .
the pre- and post - treatment photograph pairs for each subject were randomized and presented to the blinded , independent reviewers , then the reviewers were asked to determine which image was captured prior to treatment .
the degree of improvement was quantified by three of the independent physician reviewers who graded each pair of photographs from 0 ( none ) to 10 ( complete ) removal of flank fat . for any photographs that were incorrectly identified as baseline images by a reviewer
for example , an incorrectly identified baseline image that was scored an improvement score of 3 was scored as 3 in the data analysis .
subjects ranged from 33 to 56 years of age , averaging 42.2 years old and were all females .
subjects selected for the study had clearly visible fat on their flanks , and a body mass index ( bmi ) of up to 30 .
bmi was measured after measuring a subject 's height and weight ; these values were entered into an online bmi calculator ( bmi calculator , tim o 's studios , llc , austin , tx ) . for the duration of the study ,
subjects were instructed to avoid implementing major diet or lifestyle changes in order to maintain their weight within 5  lbs of baseline measurement .
cryolipolysis treatment was delivered at a cooling intensity factor 41.6 , corresponding to an average energy extraction rate of 72.9  mw / cm .
the flank fat was drawn by moderate vacuum suction between cooled plates in the applicator . at the conclusion of each 60  minute cycle ,
the treatment area was vigorously massaged by hand for 5  minutes ; then the remaining flank fat was treated using the same protocol .
thus , 4 cycles ( 2 per flank ) were administered on the treatment day , treating both flanks with 2 cycles each , overlapping 50% .
treatment efficacy was determined by blinded - expert analysis of clinical photographs viewed in pairs . at the baseline pre - treatment visit and 12-week follow - up visits
, photographs were acquired using a standardized photography set - up using a professional digital camera with a 60  mm lens ( d300 camera , nikon inc . ,
melville , ny ) with floor - standing , external , bilaterally - symmetrical strobe lighting , with 1,000  w heads and soft - boxes ( dynalite , inc . ,
subjects were photographed with their feet separated at a fixed distance using a foot positioning guide and arms in a fixed , standard position . at the completion of the study ,
clinical photographs were reviewed by four blinded , independent physicians to choose which photographs were pre- versus post - treatment photographs .
the pre- and post - treatment photograph pairs for each subject were randomized and presented to the blinded , independent reviewers , then the reviewers were asked to determine which image was captured prior to treatment .
the degree of improvement was quantified by three of the independent physician reviewers who graded each pair of photographs from 0 ( none ) to 10 ( complete ) removal of flank fat . for any photographs that were incorrectly identified as baseline images by a reviewer ,
for example , an incorrectly identified baseline image that was scored an improvement score of 3 was scored as 3 in the data analysis .
( mean 142.1  lbs . ) with their bmi ranging from 21.1 to 28.1 ( mean 24.3 ) .
of their initial baseline weights by the end of the study period ( table1 ) .
subject weight and bmi data at the treatment visit , all subjects had bmi < 29 and agreed to maintain weight over the course of the study by avoiding diet and exercise changes . at 12-week
follow - up , all subjects maintained weight within 5  lbs . of baseline .
the photographic review attempting to identify which photographs were taken before and after treatment demonstrated 94% correct identification of baseline images by four blinded , independent physician reviewers .
two reviewers correctly identified all baseline photographs and two reviewers each scored one incorrectly , thus 34 of 36 before and after pairs were correctly identified ( table2 ) .
the 0 ( none ) to 10 ( complete ) mean improvement score as rated by three blinded physician reviewers was 4.3    1.4 ( mean    sem ; table2 ; figs . 1 and 2 ) .
independent photographic review and improvement score data four blinded , independent physicians correctly identified 94% of baseline images ; 34 of 36 correct .
three physicians assigned improvement scores from 0 ( none ) to 10 ( complete ) , resulting in a mean improvement score of 4.3  +  1.4 ( mean  +  sem ) .
clinical photographs show flank fat reduction between baseline ( a , c ) and 12 weeks post - treatment ( b , d ) .
this subject had a weight gain of only 2.6  lbs . from her initial visit until the end of the study .
clinical photographs show flank fat reduction between baseline ( a , c ) and 12 weeks post - treatment ( b , d ) .
this subject lost only 0.9 lbs . from her baseline visit to her final photographic evaluation , 12 weeks later .
side - effects were mild and were limited to erythema , edema , bruising , numbness , and tingling at the treatment site .
all of the side effects resolved without intervention prior to the 12-week follow - up visit .
this study demonstrates that the new cryolipolysis applicator with a more sharply contoured vacuum cup and curved cooling panels is both safe and effective for administering cryolipolysis treatments to the flanks .
this study assessed treatment efficacy at 3 months ; whereas , other clinical studies evaluated patients at 4   and 6   months , thus the subjects presented in this study may attain some additional fat reduction with longer follow - up , or multiple treatment sessions as shown by brightman and geronemus .
the newly - designed applicator was developed to increase tissue draw and improve fit for curved surfaces like the flanks , and should allow treatment of patients who may otherwise not be able to be treated with the conventional applicator , due to the inability to gain sufficient suction and fit to keep the applicator in place .
improvement after a single treatment incorporating 2 cycles per side was a score of 4.3 on a scale of 0 ( none ) to 10 ( complete ) .
the mean 94% correct identification of baseline images by four blinded , independent physicians for this study was similar to the results shown by kaminer et al   in a much larger study , and greater than that shown by garibyan .
treated 11 subjects unilaterally on one flank and reported that blinded evaluators correctly identified the treated side in 79% of subjects .
kaminer et al . showed a 92% correct identification of baseline photographs by blinded , independent reviewers that evaluated fifty subjects treated on the flanks .
mayoral et al . treated 20 subjects to their lower abdomens and demonstrated an 86% correct identification of pre - treatment images .
this study utilized conventional 2d photography to assess treatment efficacy , and was shown to produce visible improvement that was statistically significant when evaluated by blinded physician rating of digital images .
fat reduction can also be objectively quantified by methods such as ultrasound   and 3d vectra imaging , and these methods may have more sensitivity to measure more subtle differences . in this current study , it was fortunate that the simpler , and less expensive , method of photography demonstrated statistically significant improvement .
future studies should employ multiple methods of evaluating fat reduction , to enable better comparison between different protocols .
efficacy assessment by clinical photographs may be affected by patient weight change , but this is unlikely for the current study since the subjects had an average 1.5  lb .
the weight loss is likely due to increased awareness of diet and exercise while in the study , rather than fat reduction from cryolipolysis , since small volumes of fat are removed during cryolipolysis .
this modest weight loss is not expected to affect the clinical efficacy as evaluated by blinded photographic review , and likely falls within the resolution limits of daily variations in weight and scale accuracy .
cryolipolysis has also been shown to be effective in treating areas not on the abdomen as well .
administered treatments to the lateral thigh in 40 subjects and showed 87% correct identification of pre - treatment photos .
munavalli treated 18 male subjects for pseudogynecomastia and that study demonstrated an 80% correct identification of baseline photographs .
the significant efficacy of the sharply contoured vacuum cup applicator in the current study is consistent with other studies of cryolipolysis reported in the medical literature , as is the very low side - effect profile .
future studies incorporating a series of treatment sessions to the same area should further the amount of improvement seen in the current study . treating even more sharply contoured areas such as
this study demonstrated the safety and efficacy of a new , sharply contoured vacuum cup applicator administered for a single treatment using two overlapping cycles on two flanks .
enhanced cryolipolysis clinical outcomes can be attained by selecting the appropriate applicator to maximize tissue draw for the intended treatment area and by delivering a sufficient number of cycles to adequately address the subcutaneous fat volume .
the cryolipolysis treatment protocol should be customized to the individual in order to ensure high efficacy and patient satisfaction .
 background and objectivesa sharply contoured cryolipolysis vacuum applicator was developed to improve fit and tissue draw in the abdomen and flanks to better accommodate a range of body types and a variety of treatment sites . 
 this study was carried out to evaluate the safety and efficacy of the new applicator for treatment of flank fat (  love handles).study design / materials and methodsa cryolipolysis vacuum applicator with a sharply contoured cup and curved cooling plates was used to treat 20 flanks . 
 two treatment cycles were delivered sequentially to each flank ( 60-minute cycle at a cooling intensity factor of 41.6 ) . 
 efficacy was evaluated 12 weeks post - treatment by physicians performing blinded , independent review of clinical photographs . 
 safety was assessed by the treating physician monitoring subjects for side effects and adverse events.resultsfour blinded , independent physician reviewers properly identified the pre- and post - treatment photographs 94.4% of the time . 
 improvement was scored from 0 ( none ) to 10 ( complete ) and showed an average 4.3 point ( 43% ) improvement . 
 side - effects were limited to erythema , edema , bruising , and numbness or tingling at the treatment site , and resolved without treatment.conclusionsmultiple treatment cycles from a new improved - fit cryolipolysis applicator are safe and effective for reduction of flank fat bulges . 
 a high degree of improvement was reported by blinded , physician evaluation of standardized photographs . 
 laser surg . 
 med . 
 46:731735 , 2014 . 
  2014 the authors . 
 lasers in surgery and medicine published by wiley periodicals , inc . 
Introduction
Materials and Methods
Subjects
Cryolipolysis Treatment
Photographic Evaluation of Treatment Efficacy
Side Effects
Results
Discussion
Conclusion