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NCT02007434 · ClinicalTrials.gov registry record · Phase 3
Patient Experience Study of Deoxycholic Acid Injection
A Phase 3 study, sponsored by Kythera Biopharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT02007434: Completed Phase 3 study, sponsored by Kythera Biopharmaceuticals.
NCT02007434 is a Phase 3 study that has completed, run by Kythera Biopharmaceuticals. The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02007434, a Phase 3 study, has completed, sponsored by Kythera Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study Summary
The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.
Primary Outcome
Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible).
Interventions
- DRUG Placebo
- DRUG Loratadine
- DRUG Deoxycholic Acid Injection
- OTHER Cold Compress
- DRUG Lidocaine / Epinephrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT02007434 record still lists
NCT02007434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02007434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02007434 about?
NCT02007434 is a clinical study titled "Patient Experience Study of Deoxycholic Acid Injection". The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and s...
What is the current status of trial NCT02007434?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2013-12. Estimated completion is 2014-06.
What interventions are being tested in trial NCT02007434?
The interventions under investigation include: Placebo (DRUG), Loratadine (DRUG), Deoxycholic Acid Injection (DRUG), Cold Compress (OTHER), Lidocaine / Epinephrine (DRUG).
Who is sponsoring clinical trial NCT02007434?
This trial is sponsored by Kythera Biopharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02007434's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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