Status:
COMPLETED
Kybella for the Treatment of Flank Fat (FF)
Lead Sponsor:
Beer, Kenneth R., M.D., PA
Conditions:
Adiposity
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
To Determine the safety and Effectiveness of Kybella for the treatment of Flank Fat (FF)
Detailed Description
This is a single center study of the safety and efficacy of Kybella for the treatment of subcutaneous adipose in the flank area (flank fat). Each qualified subject will undergo treatment with Kybella...
Eligibility Criteria
Inclusion
- The following are requirements for entry into the study:
- Male or female, 21 years and above
- Has mild to moderate flank fat
- Written informed consent has been obtained
- Written Authorization for Use and Release of Health and Research Study Information has been obtained
- Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
- Ability to follow study instructions and likely to complete all required visits
- If the subject is a female of childbearing potential (sexually active and not sterile, surgically sterilized, or postmenopausal for at least 1 year), have a urine pregnancy test evaluated as negative within 10 days prior to enrollment, have used contraception for at least 30 days prior to enrollment, and agree to use a reliable method of contraception for the duration of the study. Pregnancies that occur during the clinical trial will be followed by the sponsor until delivery or termination.
- Subject agrees to abstain from any treatment to the flank region including botulinum toxins, hyaluronic acid fillers, cosmetic surgery, laser/light therapy, chemical peels, etc for the duration of the study.
- \-
Exclusion
- 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 -
Key Trial Info
Start Date :
July 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04841551
Start Date
July 22 2021
End Date
March 2 2022
Last Update
April 1 2022
Active Locations (1)
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1
Kenneth Beer, MD, PA
West Palm Beach, Florida, United States, 33401