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Kybella With or Without Triamcinolone for Submental Fat Reduction
NCT03241563Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2016
- Primary completion
- Feb 2017
- Countries
- 1
- Sponsor
- Cosmetic Laser Dermatology
- Modality
- Orthosteric Ligands
- Drugs
- triamcinolone
- Conditions
- submental fat
01
Overview
Phase 4, randomised, double-blind trial of triamcinolone in submental fat (2 arms), sponsored by Cosmetic Laser Dermatology. Primary endpoint: Evaluation of Efficacy of Kybella with Triamcinolone in the Reduction of Submental Fat at 6 months. Started Apr 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Kybella alone
Sodium Deoxycholate without triamcinolone
Kybella plus triamcinolone
Sodium Deoxycholate with triamcinolone
03
Who it enrols
Healthy adults aged 18-65 with submental fat grade 2 or 3, stable weight, and no prior fat reduction treatments in the submental region.
04
Endpoints
Primary
Evaluation of Efficacy of Kybella with Triamcinolone in the Reduction of Submental Fat
Secondary
Evaluation of Safety of Kybella with Triamcinolone for Reduction of Submental Fat
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