Kybella for the Treatment of Flank Fat (FF)

NCT04841551 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: KybellaFlanks 001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adiposity

Keywords

kybella; flank fat

Outcome Measures

Primary Outcomes (1)

• Primary effectiveness measure

  The change in the appearance and rating of the flank fat through MRI study and as measured by the independent observer GAIS rating. Change in the Global Aesthetic Improvement Scale (GAIS) as measured by the principal investigator. The investigator will independently assess the subject's level of improvement on the GAIS scale, comparing the live subject with his/her pre-treatment digital image, at all follow-up visits. 5-Point Global Aestheic Improvement Scale (GAIS) Score Grade Description 2 Much Improved Marked improvement in appearance 1 Improved Improvement in appearance, but a touch-up or re-treatment is needed 0 No Change The appearance is essentially the same as the original condition * 1 Worse The appearance is worse than the original condition * 2 Much Worse The appearance is much worse than the original condition

  Week 6, Week 10

Secondary Outcomes (1)

• Secondary effectiveness measure

  Week 6, Week 10, Week 12

Study Arms (1)

Kybella Flanks

OTHER

10 subjects will be treated with Kybella in the flanks

Drug: Kybella Flanks

Interventions

Kybella Flanks DRUG

10 subjects will be treated with Kybella in the flanks

Kybella Flanks

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beer, Kenneth R., M.D., PA: lead

Study Sites (1)

Kenneth Beer, MD, PA

West Palm Beach, Florida, 33401, United States

Location

Related Publications (2)

• Pham CT, Lee A, Sung CT, Choi F, Juhasz M, Mesinkovska NA. Adverse Events of Injectable Deoxycholic Acid. Dermatol Surg. 2020 Jul;46(7):942-949. doi: 10.1097/DSS.0000000000002318.

  PMID: 31977503 BACKGROUND

• Lin MJ, Dubin DP, Schwarcz RM, Khorasani H. The Impact of Submental Deoxycholic Acid Injections on Neck Surgery. J Drugs Dermatol. 2019 Dec 1;18(12):1281.

  PMID: 31860219 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Beer, M.D.

  Research Institute of the Southeast, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: Single center, single arm open label treatment group

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 12, 2021
• Study Start: July 22, 2021
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: July 2022

Locations

US (1)