Clinical trial NCT01859091: Pilot Study on the Submental Area
Official title: Pilot Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Keywords: Lipolysis
Cryolipolysis
Fat Reduction
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.


Eligibility criteria: Inclusion Criteria

1. Male or female subjects \> 18 years of age and \< 65 years of age.
2. Presence of submental fat, which in the investigator's opinion, may benefit from the treatment.
3. No weight change exceeding 10 pounds in the preceding month.
4. Agreement to maintain his/her weight (i.e., within 10 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
5. Subject has signed a written informed consent form.

Exclusion Criteria

1. Skin laxity in the neck or chin area for which reduction in submental fat may.
2. Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
3. Enlargement on the anterior neck that may prevent the proper placement of the applicator.
4. Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area.
5. Botulinum toxin injections within the neck or chin area.
6. History of a fat reduction procedure in the area of intended treatment.
7. History of prior surgery in the area of intended treatment.
8. Current dental infection.
9. Known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
10. Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
11. Impaired skin sensation or thermal sensitivity in the intended treatment area.
12. Open or infected wounds in the intended treatment area.
13. Currently taking or has taken diet pills or weight control supplements within the past month.
14. Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
15. Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
16. Pregnant or intending to become pregnant in the next 5 months.
17. Lactating or has been lactating in the past 6 months.
18. Unable or unwilling to comply with the study requirements.
19. Currently enrolled in a clinical study of any other unapproved investigational drug or device.
20. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Primary outcomes:
measure: Evaluate safety of treatment times
timeFrame: 8-weeks post treatment
Secondary outcomes:
measure: Reduction measured by ultrasound
timeFrame: 8-weeks post treatment
measure: Photo Review
timeFrame: 8-weeks post treatment
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Innovation Research Center
state: California
Study officials:
References: