Kybella for the Treatment of Flank Fat (FF)

Completed · Phase 4

Conditions studied: Adiposity

In brief

To Determine the safety and Effectiveness of Kybella for the treatment of Flank Fat (FF)

Key facts

Study ID

NCT04841551

Run by

Beer, Kenneth R., M.D., PA

People needed

10

Starts

2021-07-22

Expected to finish

2022-03-02

Last updated by the study team

2022-04-01

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• The following are criteria for exclusion from participating in the study:
• Uncontrolled systemic disease
• Severe cardiovascular disease
• Known allergy or sensitivity to the study medication(s) or its components
• Females who are pregnant, nursing, or planning a pregnancy. If a pregnancy occurs during the study the pregnancy will be followed by the sponsor until delivery or termination.
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study.
• Previous treatment to the flanks with hyaluronic acid fillers or semi-permanent filler (i.e. Radiesse) in the past 12 months and for the duration of the study
• Any use of permanent filler materials such as Artefill or silicone in the flanks.
• Subjects planning a cosmetic procedure in the treatment area during the study period or with prior cosmetic procedures (i.e. surgery) in the treatment area or visible scars that may affect the evaluation.
• Any subjects with volume deficit due to trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIV-related disease.
• Infection or dermatoses at the injection site.
• Evidence of recent alcohol or drug abuse.
• Medical and/or psychiatric problems that are severe enough to interfere with the study results.
• Known bleeding disorder or is receiving medication that will likely increase the risk of bleeding as the result of injection.
• Has hair that would interfere with evaluation and treatment of the flank area
• Has a tendency to develop hypertrophic scarring
• Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthestics), HA products, or Streptococcal protein.
• Has porphyria
• Has an active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the flank area.
• Subject has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study -

Where it is running

• Kenneth Beer, MD, PA — West Palm Beach, Florida, United States

Full record on ClinicalTrials.gov

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