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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. 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.
This is a Single-site randomized, double-blind comparison trial of Kybella injections with or without triamcinolone acetate for the reduction of submental fat. 20 subjects will be enrolled into the trial. Of these 20 subjects, 5 will be randomized to receive Kybella injections alone whereas 15 will receive Kybella plus triamcinolone acetate in the following way:
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.
Canfield Vectra 3D imaging will be performed at baseline and at each follow up visit. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| without triamcinolone | Active Comparator | sodium Deoxycholate without triamcinolone |
|
| with triamcinolone | Active Comparator | sodium Deoxycholate with triamcinolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Deoxycholate | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Efficacy of Kybella with Triamcinolone in the Reduction of Submental Fat | evaluate the efficacy associated with Kybella injections for the reduction of fat of the upper neck in the treatment of submental fat with and without added triamcinolone acetonide. An evaluator blinded to the study will grade the level of improvement of the submental fat using the Clinician Graded Submental Fat Rating Scale. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Safety of Kybella with Triamcinolone for Reduction of Submental Fat | Differences in rates of edema, erythema, tenderness, and erosion/ulceration, based on blinded evaluator assessment, will be compared between subjects treated with Kybella with and without triamcinolone | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchel P Goldman, MD | DCLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. | San Diego | California | 92121 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 24, 2017 | |
| Reset | Nov 28, 2017 | |
| Release | Feb 12, 2019 | |
| Reset | Mar 5, 2019 | |
| Release | Apr 30, 2019 | |
| Reset | May 21, 2019 | |
| Release | Aug 15, 2019 | |
| Reset | Sep 4, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 24, 2017 | Nov 28, 2017 | |||
| Feb 12, 2019 |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Triamcinolone |
| Drug |
Triamcinolone 40mg/ml |
|
| Mar 5, 2019 |
| Apr 30, 2019 | May 21, 2019 |
| Aug 15, 2019 | Sep 4, 2019 |
| D011083 |
| Polycyclic Compounds |
| D002757 | Cholanes |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013259 | Steroids, Fluorinated |