Adiposity
Conditions
Brief summary
This study is to evaluate the efficacy, edema and pain associated with Kybella(TM) injections of the upper neck in the treatment of submental fat with varying low concentrations of triamcinolone acetonide plus low doses of lidocaine.
Detailed description
This is a two-site randomized, double-blind comparison trial of Kybella(TM) injections with or without triamcinolone acetate for the reduction of submental fat. 30 subjects will be enrolled into the trial (15 subjects per site). At each site, 5 will be randomized to receive Kybella(TM) injections alone whereas 10 will receive Kybella(TM) plus differing doses of triamcinolone acetate in the following way: 1. Group 1 (5 patients per site): Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC. 2. Group 2 (10 patients per site): Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total dose of up to 100 mg of SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point The treatment area will be bounded superiorly by a line 1 cm inferior to the mandibular margin, laterally by the sternocleidomastoid muscles, and inferiorly by the hyoid bone. The subjects and evaluating investigator will be blinded to the treatment, thus maintaining double-blind status. By nature of the varying volumes of injection, the treating investigator will be unblinded to the treatment. A series of 3 injection sessions will be performed spaced 4 weeks apart. No lidocaine will be injected prior to injections to prevent further dilution of injected Kybella™ as it will be premixed with Kybella™. Chilling with cold will be the method of pain reduction for needle insertion. Canfield Vectra 3D imaging will be performed at baseline and final visit (Appendix C) with analysis and calculation of volumetric changes performed at baseline and final visit. Photos will also be taken with the Intellistudio at all other visits. Follow up visits will be performed 3 and 5 days after each injection session to assess for side effect and tolerability profile. After the final injection session, additional follow up visits will be performed at days 90 and 180 to assess for efficacy. Subject weight will be recorded at baseline and at end of study.
Interventions
DRUGInjectable sodium deoxycholate
Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC.
COMBINATION_PRODUCTInjectable sodium deoxycholate with Triamcinolone acetate
Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total dose of up to 100 mg of SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point
Sponsors
Allergan
Maryland Laser Skin and Vein Institute
Goldman, Butterwick, Fitzpatrick and Groff
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and Outcomes Assessors will be blinded to the treatment arms subjects are randomized to.
Intervention model description
10 subjects will be part of a control group treated without triamcinolone and 20 subjects will be treated with triamcinolone.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Females or Males in good general health age 18 - 65 years of age 2. Fitzpatrick skin types I-VI 3. Must be willing to give and sign a HIPAA form and informed consent form 4. Must be willing and able to comply with all study protocols and schedules 5. Must have submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (PR-SMFRS) 6. Negative urine pregnancy test prior to each treatment (if applicable) 7. Female patients will be either of non-childbearing potential defined as: 7.1 Having no uterus 7.2 No menses for at least 12 months. Or; (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as: 7.3 Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device 7.4 Intrauterine coil 7.5 Bilateral tubal ligation 7.6 Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom) 7.7 Abstinence (If practicing abstinence must agree to use barrier method described above (7.6) if becomes sexually active) 7.8 Vasectomized partner (must agree to use barrier method described above (7.6) if becomes sexually active with unvasectomized partner) 8. Males must be willing to be clean shaven for all study visits 9. The patient must have had a stable weight (no fluctuation of \>15 pounds in a year), diet, and physical activity for the previous 6 months
Exclusion criteria
1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial 2. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study 3. Treatment with botulinum toxin injections in the neck or chin area within 6 months before randomization 4. Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area 5. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study 6. An active dermatitis or open wound in the proposed treatment area 7. An active bacterial, fungal, or viral infection in the proposed treatment area 8. Pre-existing skin condition to the submental region that may confound evaluation or analysis, at investigator discretion 9. Previously treated with subcutaneous sodium deoxycholate to the submental region 10. Previously treated with focused ultrasound, radiofrequency, cryolipolysis or liposuction to the submental region within the previous 6 months 11. Any other laser, light energy device, or chemical peel treatment to the submental region within the previous 3 months 12. Pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia or facial nerve palsy 13. Pre-existing medical condition other than increased submental fat that may result in increased submental fullness such as but not limited to thyroid enlargement, goiter, cervical lymphadenopathy etc., at investigator discretion 14. Must not have a planned fat reduction procedure of any variety to the submental region for the duration of the study 15. Must not have planned significant alterations in diet or physical activity that may result in significant fluctuations in weight 16. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician-Reported Submental Fat Rating Scale | 90 Days from Baseline | Change in efficacy will be measured from Baseline to 90 days post final treatment using a 5-point Clinician-Reported Submental Fat Rating Scale ranging from Absent (score of 0) to Extreme submental convexity (score of 4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician-Reported Submental Laxity Rating Scale | 90 days from baseline | Laxity will be compared between treatment groups at each post-treatment time point through Day 90 using a 5-Point Clinician Evaluation of Side Effects Scale ranging from None (score of 0) to Severe (score of 4). |
| Subject Satisfaction Rating Scale | Post-treatment to Day 180 | Satisfaction will be compared between treatment groups at each post-treatment time point through Day 180 using a 7-point satisfaction scale rating from extremely dissatisfied (score of 0) to extremely satisfied (score of 6). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Control Group (5 patients per site): Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline delivered in up to 50 injections per treatment session.
Injectable sodium deoxycholate: Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC. | 10 |
| w/ Triamcinolone Experimental Group (10 patients per site): Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate and 0.2 mL of 1% lidocaine with no epinephrine delivered in up to 50 injections per treatment session.
Injectable sodium deoxycholate with Triamcinolone acetate: Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total dose of up to 100 mg of SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point | 20 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Control | w/ Triamcinolone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 30 Participants |
| Age, Continuous | 46.2 years | 46.55 years | 46.38 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 19 Participants | 29 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 10 |
| other Total, other adverse events | 1 / 20 | 0 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 10 |
Outcome results
Primary
Change in Clinician-Reported Submental Fat Rating Scale
Change in efficacy will be measured from Baseline to 90 days post final treatment using a 5-point Clinician-Reported Submental Fat Rating Scale ranging from Absent (score of 0) to Extreme submental convexity (score of 4)
Time frame: 90 Days from Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Change in Clinician-Reported Submental Fat Rating Scale | 2-point improvement | 5 Participants |
| Control | Change in Clinician-Reported Submental Fat Rating Scale | 1-point improvement | 5 Participants |
| Control | Change in Clinician-Reported Submental Fat Rating Scale | no improvement | 0 Participants |
| Control | Change in Clinician-Reported Submental Fat Rating Scale | lost to follow up/withdrew from study | 0 Participants |
| w/ Triamcinolone | Change in Clinician-Reported Submental Fat Rating Scale | lost to follow up/withdrew from study | 5 Participants |
| w/ Triamcinolone | Change in Clinician-Reported Submental Fat Rating Scale | 2-point improvement | 4 Participants |
| w/ Triamcinolone | Change in Clinician-Reported Submental Fat Rating Scale | no improvement | 5 Participants |
| w/ Triamcinolone | Change in Clinician-Reported Submental Fat Rating Scale | 1-point improvement | 6 Participants |
Secondary
Change in Clinician-Reported Submental Laxity Rating Scale
Laxity will be compared between treatment groups at each post-treatment time point through Day 90 using a 5-Point Clinician Evaluation of Side Effects Scale ranging from None (score of 0) to Severe (score of 4).
Time frame: 90 days from baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Change in Clinician-Reported Submental Laxity Rating Scale | 2-point improvement | 3 Participants |
| Control | Change in Clinician-Reported Submental Laxity Rating Scale | 1-point improvement | 2 Participants |
| Control | Change in Clinician-Reported Submental Laxity Rating Scale | no improvement | 5 Participants |
| Control | Change in Clinician-Reported Submental Laxity Rating Scale | lost to follow up/withdrew from study | 0 Participants |
| w/ Triamcinolone | Change in Clinician-Reported Submental Laxity Rating Scale | lost to follow up/withdrew from study | 5 Participants |
| w/ Triamcinolone | Change in Clinician-Reported Submental Laxity Rating Scale | 2-point improvement | 2 Participants |
| w/ Triamcinolone | Change in Clinician-Reported Submental Laxity Rating Scale | no improvement | 9 Participants |
| w/ Triamcinolone | Change in Clinician-Reported Submental Laxity Rating Scale | 1-point improvement | 4 Participants |
Secondary
Subject Satisfaction Rating Scale
Satisfaction will be compared between treatment groups at each post-treatment time point through Day 180 using a 7-point satisfaction scale rating from extremely dissatisfied (score of 0) to extremely satisfied (score of 6).
Time frame: Post-treatment to Day 180
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Subject Satisfaction Rating Scale | extremely satisfied | 1 Participants |
| Control | Subject Satisfaction Rating Scale | satisfied | 7 Participants |
| Control | Subject Satisfaction Rating Scale | slightly satisfied | 0 Participants |
| Control | Subject Satisfaction Rating Scale | neither satisfied nor dissatisfied | 0 Participants |
| Control | Subject Satisfaction Rating Scale | slightly dissatisfied | 0 Participants |
| Control | Subject Satisfaction Rating Scale | dissatisfied | 1 Participants |
| Control | Subject Satisfaction Rating Scale | extremely dissatisfied | 0 Participants |
| Control | Subject Satisfaction Rating Scale | lost to follow up/withdrew from study | 1 Participants |
| w/ Triamcinolone | Subject Satisfaction Rating Scale | lost to follow up/withdrew from study | 5 Participants |
| w/ Triamcinolone | Subject Satisfaction Rating Scale | extremely satisfied | 7 Participants |
| w/ Triamcinolone | Subject Satisfaction Rating Scale | slightly dissatisfied | 3 Participants |
| w/ Triamcinolone | Subject Satisfaction Rating Scale | satisfied | 1 Participants |
| w/ Triamcinolone | Subject Satisfaction Rating Scale | extremely dissatisfied | 0 Participants |
| w/ Triamcinolone | Subject Satisfaction Rating Scale | slightly satisfied | 1 Participants |
| w/ Triamcinolone | Subject Satisfaction Rating Scale | dissatisfied | 0 Participants |
| w/ Triamcinolone | Subject Satisfaction Rating Scale | neither satisfied nor dissatisfied | 3 Participants |