A Phase 4 interventional study of Kybella Flanks in Adiposity, sponsored by Beer, Kenneth R., M.D., PA. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by Beer, Kenneth R., M.D., PA · Phase 4, Interventional, and Treatment
To Determine the safety and Effectiveness of Kybella for the treatment of Flank Fat (FF)
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.
6,583 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 10 is below the median of 77 across 5,091 interventional studies indexed under Obesity.
Browse Obesity studies →Beer, Kenneth R., M.D., PA is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:The following are requirements for entry into the study:
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.
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Exclusion Criteria:
The following are criteria for exclusion from participating in the study:
10 subjects will be treated with Kybella in the flanks
Drug: Kybella Flanks
10 subjects will be treated with Kybella in the flanks
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
Time frame: Week 6, Week 10
Secondary effectiveness measure
The secondary effectiveness measure is subject responses to the subject Satisfaction with a GAIS Scoring system. 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
Time frame: Week 6, Week 10, Week 12
Plan to share: Yes
Supporting information: Clinical study report
Time frame: July 2022
Ran from Jul 2021 to primary completion in Mar 2022, 7 months.
Of 113 non-industry phase 4 interventional studies under Obesity, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 81. This study's 7 months is below that.
Counting every sponsor, half of 128 studies reached it within 39 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Beer, Kenneth R., M.D., PA