Safety and efficacy of cryolipolysis for non-invasive reduction of submental fat

Suzanne L Kilmer, A Jay Burns, Brian D Zelickson, Suzanne L Kilmer, A Jay Burns, Brian D Zelickson

Abstract

Background and objectives: Cryolipolysis has previously received FDA clearance for fat reduction in the abdomen, flanks, and thighs. There is also interest in small volume fat reduction for areas such as the chin, knees, and axilla. This article reports the results of a cryolipolysis pivotal IDE study for reduction of submental fullness.

Study design/material and methods: A prototype small volume vacuum applicator (CoolMini applicator, CoolSculpting System, ZELTIQ Aesthetics) was used to treat 60 subjects in the submental area. At each treatment visit, a single treatment cycle was delivered at -10°C for 60 minutes, the same temperature and duration used in current commercially-available cryolipolysis vacuum applicators. At the investigator's discretion, an optional second treatment was delivered 6 weeks after the initial treatment. The primary efficacy endpoint was 80% correct identification of baseline photographs by independent physician review. The primary safety endpoint was monitoring incidence of device- and/or procedure-related serious adverse events. Secondary endpoints included assessment of fat layer thickness by ultrasound and subject satisfaction surveys administered 12 weeks after final cryolipolysis treatment.

Results: Independent photo review from 3 blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicated mean fat layer reduction of 2.0 mm. Patient questionnaires revealed 83% of subjects were satisfied, 80% would recommend submental cryolipolysis to a friend, 77% reported visible fat reduction, 77% felt that their appearance improved following the treatment, and 76% found the procedure to be comfortable. No device- or procedure-related serious adverse events were reported.

Conclusion: The results of this clinical evaluation of 60 patients treated in a pivotal IDE study demonstrate that submental fat can be reduced safely and effectively with a small volume cryolipolysis applicator. Patient surveys revealed that submental cryolipolysis was well-tolerated, produced visible improvement in the neck contour, and generated high patient satisfaction. These study results led to FDA clearance of cryolipolysis for submental fat treatment.

Keywords: ATX-101; cryolipolysis; non-invasive body contouring; non-surgical fat reduction; subcutaneous fat; submental fat; submentum.

© 2015 Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
Prototype small volume applicator (A) side view and (B) top view showing contoured cooling surface.
Figure 2
Figure 2
Cryolipolysis treatment steps for the submental area. (A) The small volume applicator was secured by vacuum suction and velcro straps. (B) Frozen tissue immediately following applicator removal. (C) Manual massage of the treatment area. D) Normalized tissue contour and lingering erythema following massage.
Figure 3
Figure 3
Baseline (A, C) and 12 week post‐treatment (B, D) photos for a 36 year‐old female. Weight change −3.5 lbs. (−2%) from baseline. Procedure by Dr. Brian Zelickson.
Figure 4
Figure 4
Baseline (A, C) and 12 week post‐treatment (B, D) photos for a 39 year‐old female. Weight change −4.4 lbs. (−3%) from baseline. Procedure by Dr. Suzanne Kilmer.
Figure 5
Figure 5
Baseline (A, C) and 12 week post‐treatment (B, D) photos for a 50 year‐old female. Weight change +1.7 lbs. (+1%) from baseline. Procedure by Dr. Jay Burns.
Figure 6
Figure 6
Baseline (A, C) and 12 week post‐treatment (B, D) photos for a 58 year‐old male. Weight change +2.4 lbs. (+1%) from baseline. Procedure by Dr. Brian Zelickson.
Figure 7
Figure 7
Baseline (A, C) and 12 week post‐treatment (B, D) photos for a 58 year‐old female. Weight change −8.2 lbs. (−5%) from baseline. Procedure by Dr. Suzanne Kilmer.
Figure 8
Figure 8
Baseline (A, C) and 12 week post‐treatment (B, D) photos for a 55 year‐old female. Weight change −1.4 lbs. (−1%) from baseline. Procedure by Dr. Jay Burns.
Figure 9
Figure 9
Baseline (A, C) and 12 week post‐treatment (B, D) photos for a 44 year‐old female. Weight change −4.5 lbs. (‐3%) from baseline. Procedure by Dr. Brian Zelickson.
Figure 10
Figure 10
Baseline (A, C) and 12 week post‐treatment (B, D) ultrasound images and photos demonstrate fat layer reduction for a 47 year‐old male. Lines indicate the skin layer at the top of the ultrasound images and the fat thickness. Weight change −4.2 lbs. (−2%) from baseline. Procedure by Dr. Suzanne Kilmer.

References

    1. American Society for Dermatologic Surgery (ASDS) 2015. Consumer Survey on Cosmetic Dermatologic Procedures.
    1. Schlessinger J, Weiss SR, Jewell M, Narurkar V, Weinkle S, Gold MH, Bazerkanian E. Perceptions and practices in submental fat treatment: A survey of physicians and patients. Skinmed 2013; 11(1):27–31.
    1. American Society for Aesthetic Plastic Surgery (ASAPS) 2014. Cosmetic Surgery National Data Bank Statistics.
    1. Jianu DM, Filipescu M, Jianu SA, Nita AC, Chirita DA. The synergy between lasers and adipose surgery in face and neck rejuvenation: A new approach from personal experience. Laser Ther 2012; 21(3):215–222.
    1. Hatef DA, Koshy JC, Sandoval SE, Echo AP, Izaddoost SA, Hollier LH. The submental fat compartment of the neck. Semin Plast Surg 2009; 23(4):288–291.
    1. Patel BC. Aesthetic surgery of the aging neck: Options and techniques. Orbit 2006; 25(4):327–356. Review.
    1. Duncan D, Rotunda AM. Injectable therapies for localized fat loss: State of the art. Clin Plast Surg 2011; 38(3):489–501.
    1. McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B. Results from a pooled analysis of two European, randomized, placebo‐controlled, phase 3 studies of ATX‐101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg 2014; 38(5):849–860.
    1. Ascher B, Hoffmann K, Walker P, Lippert S, Wollina U, Havlickova B. Efficacy, patient‐reported outcomes and safety profile of ATX‐101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: Results from a phase III, randomized, placebo‐controlled study. J Eur Acad Dermatol Venereol 2014; 28(12):1707–1715.
    1. Rzany B, Griffiths T, Walker P, Lippert S, McDiarmid J, Havlickova B. Reduction of unwanted submental fat with ATX‐101 (deoxycholic acid), an adipocytolytic injectable treatment: Results from a phase III, randomized, placebo‐controlled study. Br J Dermatol 2014; 170(2):445–453.
    1. Phase 3 Study of Deoxycholic Acid Injection (ATX‐101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area. Data accessed from U.S. National Institutes of Health website identifier NCT 0154 6142.
    1. Phase 3 Study of Deoxycholic Acid Injection (ATX‐101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area (REFINE‐1). Data accessed from U.S. National Institutes of Health website identifier NCT01542034.
    1. 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 2009; 40:595–604.
    1. Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Rhoades RW, Manstein D. Cryolipolysis for non invasive fat cell destruction: Initial results from a pig model. Dermatol Surg 2009; 35:1462–1470.
    1. Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med 2009; 41(10):703–708.
    1. Stevens WG, Bachelor EP. Cryolipolysis conformable surface applicator for non‐surgical fat reduction in lateral thighs. Aesthet Surg J 2015; 35(1):66–71.
    1. Munavalli GS, Panchaprateep R. Cryolipolysis for targeted fat reduction and improved appearance of the enlarged male breast. Dermatol Surg 2015; 41(9):1043–1051.
    1. Zelickson BD, Burns AJ, Kilmer SL. Cryolipolysis for safe and effective inner thigh fat reduction. Lasers Surg Med 2015; 47(2):120–127.
    1. Jalian HR, Avram MM, Garibyan L, Mihm MC, Anderson RR. Paradoxical adipose hyperplasia after cryolipolysis. JAMA Dermatol 2014; 150(3):317–319.
    1. Carruthers J, Stevens WG, Carruthers A, Humphrey S. Cryolipolysis and skin tightening. Dermatol Surg 2014; 40(Suppl 12):S184–S189.
    1. Stevens WG. Does cryolipolysis lead to skin tightening? A first report of cryodermadstringo. Aesthet Surg J 2014; 34(6):NP32–NP34.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi