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

NCT03241563 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-07

No results posted yet for this 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.

Conditions

  • Fat Reduction

Interventions

DRUG

Sodium Deoxycholate

DRUG

Triamcinolone

Triamcinolone 40mg/ml

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Goldman, Butterwick, Fitzpatrick and Groff

    lead OTHER

Principal Investigators

  • Mitchel P Goldman, MD · DCLA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03241563 on ClinicalTrials.gov