Status:
COMPLETED
Subcutaneous Fat Reduction in the Submental Area
Lead Sponsor:
Zeltiq Aesthetics
Conditions:
Body Fat Disorder
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using Cryolipolysis. Healthy adult men and women with submental skin fold thickness \> 1cm who desire reduction of subm...
Detailed Description
Non-invasive treatment for subcutaneous fat reduction in the submental area.
Eligibility Criteria
Inclusion
- Male or female subjects \> 22 years of age and \< 65 years of age.
- Submental skin fold thickness \> 1cm (measured by caliper).
- No weight change exceeding 5% of body weight in the preceding month.
- Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
- Subject has signed a written informed consent form.
Exclusion
- Skin laxity in the neck or chin area for which reduction in submental fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
- Prominent platysmal bands at rest which may interfere with assessment of submental fat
- Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
- Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
- Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area (below the mandible) within the past 6 months.
- Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the mandible) within the past 6 months.
- History of facial nerve paresis or paralysis (such as Bell's palsy).
- History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
- History of prior neck surgery, or prior surgery in the area of intended treatment.
- Current dental infection.
- Known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Currently taking or has taken diet pills or weight control supplements within the past month.
- Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
- Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
- Pregnant or intending to become pregnant in the next 6 months.
- Lactating or has been lactating in the past 6 months.
- Unable or unwilling to comply with the study requirements.
- Currently enrolled in a clinical study of an unapproved investigational drug or device.
- 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.
Key Trial Info
Start Date :
November 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02298322
Start Date
November 11 2014
End Date
August 2 2015
Last Update
September 24 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Laser & Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
2
Zel Skin & Laser Specialists
Edina, Minnesota, United States, 55424
3
EpiCentre Skin and Laser Center
Plano, Texas, United States, 75024