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NCT03241563 · ClinicalTrials.gov registry record · Phase 4

Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat

A Phase 4 study, sponsored by Goldman, Butterwick, Fitzpatrick and Groff.

Completed
Registry status
Phase 4
Development phase
20
Enrollment target

NCT03241563: Completed Phase 4 study, sponsored by Goldman, Butterwick, Fitzpatrick and Groff.

NCT03241563 is a Phase 4 study that has completed, run by Goldman, Butterwick, Fitzpatrick and Groff. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03241563, a Phase 4 study, has completed, sponsored by Goldman, Butterwick, Fitzpatrick and Groff.

COMPLETED
Registry status
Phase 4
Development phase
20 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Interventions

  • DRUG Triamcinolone
  • DRUG Sodium Deoxycholate

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2016-04
Est. Completion 2017-02
Phase Phase 4

What the finished NCT03241563 record still lists

NCT03241563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Triamcinolone is the first listed.

NCT03241563 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03241563 about?

NCT03241563 is a clinical study titled "Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone for Reduction of Submental Fat". 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. Canf...

What is the current status of trial NCT03241563?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2016-04. Estimated completion is 2017-02.

What interventions are being tested in trial NCT03241563?

The interventions under investigation include: Triamcinolone (DRUG), Sodium Deoxycholate (DRUG).

Who is sponsoring clinical trial NCT03241563?

This trial is sponsored by Goldman, Butterwick, Fitzpatrick and Groff, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03241563's enrollment target sits among peer trials

20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT03241563, the US trial registry maintained by the National Library of Medicine. NCT03241563 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.