AdiposityPhase 4NCT04841551
Kybella for the Treatment of Flank Fat (FF)
A Phase 4 study testing Kybella Flanks in people with Adiposity, run by Beer, Kenneth R., M.D., PA at 1 site in United States.
Trial summary
To Determine the safety and Effectiveness of Kybella for the treatment of Flank Fat (FF) Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adiposity
- What is being tested?
- Kybella Flanks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2021to 2 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 20Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
Kenneth Beer, MD, PA
West Palm Beach, Florida, 33401
About this study
To Determine the safety and Effectiveness of Kybella for the treatment of Flank Fat (FF)
Read the 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
- Being tested
- Kybella Flanks
- Keywords
- kybella, flank fat
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kybella FlanksDrug
10 subjects will be treated with Kybella in the flanks
| Study group | Role | What they receive |
|---|---|---|
| Kybella Flanks | Other | 10 subjects will be treated with Kybella in the flanks Receives: Drug: Kybella Flanks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 6, Week 10
Secondary outcomes (1)
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
Measured: Week 6, Week 10, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start22 Jul 2021
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AdiposityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, single arm open label treatment group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beer, Kenneth R., M.D., PA
- Responsible party
- Sponsor
- Investigators
- Kenneth Beer, M.D., Principal investigator, Research Institute of the Southeast, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841551
- Sponsor's protocol ID
- KybellaFlanks 001
- Status last verified
- Mar 2022
- First submitted
- 24 Mar 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31977503Lin 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.
PubMed 31860219
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kybella for the Treatment of Flank Fat (FF)
- ClinicalTrials.gov ID
- NCT04841551
- Acronym / sponsor ID
- KybellaFlanks 001
- Conditions
- Adiposity
- Keywords
- kybella, flank fat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Beer, Kenneth R., M.D., PA
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, single arm open label treatment group
| Arm | Type | Receives |
|---|---|---|
| Kybella Flanks | Other | Drug: Kybella Flanks10 subjects will be treated with Kybella in the flanks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kybella Flanks10 subjects will be treated with Kybella in the flanks | Drug | Kybella Flanks |
Primary outcome
Primary effectiveness measure
Time frame: Week 6, Week 10
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
1 secondary outcome
Secondary effectiveness measure
Time frame: Week 6, Week 10, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 31977503Pham 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.
- Background: PubMed 31860219Lin 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Beer, M.D. principal investigator
Research Institute of the Southeast, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kybella Flanks in people with Adiposity, run by Beer, Kenneth R., M.D., PA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary effectiveness measure (time frame: Week 6, Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841551, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.