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Kybella With Triamcinolone

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ClinicalTrials.gov Identifier: NCT03361176
Recruitment Status : Completed
First Posted : December 4, 2017
Results First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborators:
Allergan
Maryland Laser Skin and Vein Institute
Information provided by (Responsible Party):
Goldman, Butterwick, Fitzpatrick and Groff

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Adiposity
Interventions Drug: Injectable sodium deoxycholate
Combination Product: Injectable sodium deoxycholate with Triamcinolone acetate
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control w/ Triamcinolone
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 10 20
Completed 9 15
Not Completed 1 5
Reason Not Completed
Lost to Follow-up             1             2
Adverse Event             0             2
Withdrawal by Subject             0             1
Arm/Group Title Control w/ Triamcinolone Total
Hide Arm/Group Description

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.

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

Total of all reporting groups
Overall Number of Baseline Participants 10 20 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
20
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 20 participants 30 participants
46.2
(29 to 62)
46.55
(28 to 63)
46.38
(28 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
Female
10
 100.0%
18
  90.0%
28
  93.3%
Male
0
   0.0%
2
  10.0%
2
   6.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
Female
10
 100.0%
18
  90.0%
28
  93.3%
Male
0
   0.0%
2
  10.0%
2
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   5.0%
1
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
10
 100.0%
19
  95.0%
29
  96.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 20 participants 30 participants
10 20 30
1.Primary Outcome
Title Change in Clinician-Reported Submental Fat Rating Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control w/ Triamcinolone
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 10 20
Measure Type: Count of Participants
Unit of Measure: Participants
2-point improvement
5
  50.0%
4
  20.0%
1-point improvement
5
  50.0%
6
  30.0%
no improvement
0
   0.0%
5
  25.0%
lost to follow up/withdrew from study
0
   0.0%
5
  25.0%
2.Secondary Outcome
Title Change in Clinician-Reported Submental Laxity Rating Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control w/ Triamcinolone
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 10 20
Measure Type: Count of Participants
Unit of Measure: Participants
2-point improvement
3
  30.0%
2
  10.0%
1-point improvement
2
  20.0%
4
  20.0%
no improvement
5
  50.0%
9
  45.0%
lost to follow up/withdrew from study
0
   0.0%
5
  25.0%
3.Secondary Outcome
Title Subject Satisfaction Rating Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control w/ Triamcinolone
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 10 20
Measure Type: Count of Participants
Unit of Measure: Participants
extremely satisfied
1
  10.0%
7
  35.0%
satisfied
7
  70.0%
1
   5.0%
slightly satisfied
0
   0.0%
1
   5.0%
neither satisfied nor dissatisfied
0
   0.0%
3
  15.0%
slightly dissatisfied
0
   0.0%
3
  15.0%
dissatisfied
1
  10.0%
0
   0.0%
extremely dissatisfied
0
   0.0%
0
   0.0%
lost to follow up/withdrew from study
1
  10.0%
5
  25.0%
Time Frame Adverse event data were collected over 180 days.
Adverse Event Reporting Description Kybella is non-significant risk when injected submental by the package insert. This study is a phase 4 trial. Product safety has been demonstrated in prior studies.
 
Arm/Group Title w/ Triamcinolone Control
Hide Arm/Group Description Adverse events related to Triamcinolone Group Adverse events related to Control Group
All-Cause Mortality
w/ Triamcinolone Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
w/ Triamcinolone Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
w/ Triamcinolone Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/10 (0.00%)    
Musculoskeletal and connective tissue disorders     
Neck pain secondary to motor vehicle accident *  1/20 (5.00%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders     
Erosion * [1]  1/20 (5.00%)  1 0/10 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Erosion of skin within the submental treatment area
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert A. Weiss, MD
Organization: Maryland Laser Skin and Vein
Phone: 4106662839
EMail: cmyers@mdlsv.com
Layout table for additonal information
Responsible Party: Goldman, Butterwick, Fitzpatrick and Groff
ClinicalTrials.gov Identifier: NCT03361176     History of Changes
Other Study ID Numbers: Kybelladose-2017-02
First Submitted: November 21, 2017
First Posted: December 4, 2017
Results First Submitted: March 21, 2019
Results First Posted: May 9, 2019
Last Update Posted: May 9, 2019