NL-OMON51182
Withdrawn
Not Applicable
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) - MED-MA-PLS-0647
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- on-Invasive Fat Reduction
- Sponsor
- Allergan Aesthetics, an AbbVie Company
- Enrollment
- 11
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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