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Patient Experience Study of Deoxycholic Acid Injection

NCT02007434 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2015-07-28

Study results available
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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.

Conditions

  • Moderate or Severe Submental Fullness

Interventions

DRUG

Deoxycholic Acid Injection

Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.

DRUG

Placebo

Phosphate buffered saline placebo for injection

OTHER

Cold Compress

A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.

DRUG

Lidocaine / Epinephrine

Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.

DRUG

Loratadine

Loratadine 10 mg orally from Day -7 until Day 7

DRUG

Ibuprofen

Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.

OTHER

Compression Chin Strap

A compression chin strap was applied 15 minutes after dosing for at least 24 hours.

Sponsors & Collaborators

  • Kythera Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Frederick Beddingfield, III, MD, PhD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT02007434 on ClinicalTrials.gov