NCT04841551

Kybella for the Treatment of Flank Fat (FF)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Beer, Kenneth R., M.D., PA · Individual
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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 in the flank region for the reduction of flank fat.. Prior to treatment, the principal investigator will evaluate the severity of the subcutaneous adipose deposition of the flanks. Subjects will also have an MRI of the flanks at screening and week 12. .. Flank digital images will be taken prior to treatment and at each subsequent visit. The subjects will complete a safety and injection site response (ISR) diary beginning on the evening of treatment. The subjects will return at Week 6 for additional treatment if warranted by the treating investigator. Subjects will be contacted via a phone call within 72 hours after each injection. Subjects will be seen at Week 6, 10, 12 and 18 (EOS) after initial treatment, at which time the subject will undergo photography and the investigator will rate treatment improvement (GAIS). The investigator will evaluate the treatment area for any adverse events (AEs). MRI study will be done at screening and at week 12. The subject will return 6 weeks after initial treatment, and the principal investigator will determine if a touch-up treatment is warranted. If deemed necessary, a touch-up treatment may be administered Digital photography will be captured prior to treatment and following treatment. The subject will return 4 weeks after the touch-up to undergo digital photography and for the principal investigator to assess safety/improvement. After initial treatment routine follow-up visits for safety and effectiveness will occur at Week 6, 10, 12, and 18 (EOS). A phone call will occur within 72 hours following injection. At all follow-up visits, digital photography will be captured and the investigator will rate treatment improvement (GAIS).. At screening and at Week 6, 10, 12 and 18 (EOS) subjects will complete the satisfaction of flank region questionnaire. The goal of this study will be to assess the feasibility and efficacy of injecting Kybella for the treatment of subcutaneous fat of the flank region.

Conditions

• Adiposity

Interventions

Type	Name	Description
DRUG	Kybella Flanks	10 subjects will be treated with Kybella in the flanks

Timeline

• Start date: 2021-07-22
• Primary completion: 2022-03-02
• Completion: 2022-03-02
• First posted: 2021-04-12
• Last updated: 2022-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study