Multi Country Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs and Submental Area (NuCOOL)
- Conditions
- on-Invasive Fat ReductionFat reduction
- Registration Number
- NL-OMON51182
- Lead Sponsor
- Allergan Aesthetics, an AbbVie Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 11
1. Participant must be in good health as determined by medical history,
physical examination, vital signs, and investigator*s judgment, including no
known active pandemic infection.
2. Participant (healthy volunteers) has read and signed the study written ICF.
3. Male or female participant 22 to 65 years of age inclusive at screening.
4. Participant has clearly visible and palpable fat in the abdomen and flanks,
and participant may also be assessed for visible and palpable fat in one or
more of the following body areas: left and right lower aspects of the upper
arms, left and right inner thigh, left and right outer thigh, or submental
area, which in the investigator*s opinion is appropriate for and may benefit
from treatment.
5. Participant agrees to receive treatment of the abdomen and flanks
(collectively, the midsection) and has option to receive treatment to at least
1 additional body area listed in criterion 4.
6. Participant has not had weight change fluctuations exceeding 5% of body
weight in the preceding month.
7. Participant has a BMI of * 18.5 and < 30. BMI is defined as weight in
kilograms divided by height in meters squared (kg/m2).
8. Participant agrees to maintain weight (ie, within 5% of body weight) by not
making any changes in diet or exercise routine during the course of the study.
9. Participant agrees to have photographs taken of the treatment area(s) during
the scheduled time periods
1. Participant has a history of an invasive fat reduction procedure (eg,
liposuction, surgery, lipolytic agents, etc) within or adjacent to the area
being considered for treatment.
2. Participant has implants (eg, breast implants) in or immediately adjacent to
the area of intended treatment.
3. Participant has a history of prior surgery or scar tissue related to the
area being considered for treatment.
4. Participant has a known history of cryoglobulinemia, cold urticaria, cold
agglutinin disease, or paroxysmal cold hemoglobinuria.
5. Participant has a known sensitivity to cold or has any condition with a
known response to cold exposure that limits blood flow to the skin, such as
cold urticaria, Raynaud*s disease, or chilblains (pernio).
6. Participant with a clinically significant bleeding disorder, or concomitant
use of blood thinners, or is taking any medication that, in the investigator*s
opinion, may significantly increase the participant*s risk of bruising or
bleeding. Participant on low dose aspirin for medical condition is excluded if
the medical history suggests significant risk of bruising or bleeding per
investigator*s clinical judgement.
7. Participant has a history of carpal tunnel syndrome, compartment syndrome,
or deep vein thrombosis in the upper or lower extremities (only applicable for
participants receiving treatment to the upper arms or thighs).
8. Participant is currently taking or has taken diet pills or weight control
supplements within the past 6 months.
9. Participant has any skin conditions, such as moderate to excessive skin
laxity, open wound, or scars, and active infection, eczema, dermatitis or
rashes in the location of the treatment sites that may interfere with the
treatment or evaluation (stretch marks are not an exclusion).
10. Participant has an active implanted device such as a pacemaker,
defibrillator, drug delivery system, or any other metal-containing implant,
within or adjacent to the area being considered for treatment.
11. Participant (WOCBP) is pregnant or intending to become pregnant in the next
3 to 6 months and does not agree to use reliable contraception during the study.
12. Participant is lactating or has been lactating in the past 6 months.
13. Participant is unable or unwilling to comply with the study requirements.
14. Participant is currently enrolled in a clinical study of any unapproved
investigational device, investigational product, or any other type of medical
research judged not to be scientifically or medically compatible with this
study.
15. Participant has any other condition or laboratory value that would, in the
professional opinion of the investigator, potentially affect the participant*s
response or the integrity of the data or would pose an unacceptable risk to the
participant.
16. Participant has had a non-invasive fat reduction and/or body contouring
procedure in the area(s) of intended treatment within the past 12 months.
17. Participant needs to administer, or has a known history of subcutaneous
injections, into the area(s) of intended treatment (eg, cortisone, heparin,
insulin) within the past 6 months.
18. Participant with known sensitivity or allergy to fructose, glycerin,
isopropyl alcohol, or propylene glycol.
19. Participant has impaired peripheral circulation in the area to be treat
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary effectiveness endpoint is the proportion of participants with<br /><br>*satisfied* or *very satisfied* on the item 1 for the CSQ-Midsection, measured<br /><br>at Week 12 (Visit 8) for participants who receive 1 treatment session, or at<br /><br>Week 20 (Visit 9) for participants who receive 2 treatment sessions</p><br>
- Secondary Outcome Measures
Name Time Method