Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area (SMF) Using Magnetic Resonance Imaging (MRI) and a Battery of Clinician- and Subject-reported Measurements.

Sponsors

Lead Sponsor: Kythera Biopharmaceuticals

Source Kythera Biopharmaceuticals
Brief Summary

Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Overall Status Completed
Start Date 2009-12-01
Completion Date 2010-12-01
Primary Completion Date 2010-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Secondary Outcome
Measure Time Frame
Change From Baseline in Submental Fat Volume Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Change From Baseline in Submental Fat Thickness Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Enrollment 129
Condition
Intervention

Intervention Type: Drug

Intervention Name: Deoxycholic acid injection

Intervention Type: Drug

Intervention Name: Placebo

Description: Phosphate buffered saline placebo for injection

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria: - Moderate or severe submental fat - Dissatisfaction with submental area - History of stable body weight - Signed informed consent Exclusion Criteria: - Any medical or other condition that would affect subject safety or evaluation of efficacy - Previous intervention in the submental area

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Frederick Beddingfield, MD, PhD Study Director Kythera Biopharmaceuticals, Inc.
Location
Facility:
Investigational Site | Birmingham, Alabama, 35205, United States
Investigational Site | Beverly Hills, California, 90210, United States
Investigational Site | Beverly Hills, California, 90212, United States
Investigational Site | San Francisco, California, 94115, United States
Investigational Site | Naperville, Illinois, 60563, United States
Investigational Site | Chestnut Hill, Massachusetts, 02467, United States
Investigational Site | Fridley, Minnesota, 55432, United States
Investigational Site | St. Louis, Missouri, 63141, United States
Investigational Site | Omaha, Nebraska, 68144, United States
Investigational Site | Plano, Texas, 75093, United States
Location Countries

United States

Verification Date

2015-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Label: Deoxycholic acid Injection 1 mg/cm²

Type: Experimental

Description: Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Label: Deoxycholic acid Injection 2 mg/cm²

Type: Experimental

Description: Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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