Clinical trial NCT00618722: Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Official title: Phase 1-2, Multicenter, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) for the Reduction of Subcutaneous Fat in the Submental Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Moderate or Severe Submental Fullness
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 85
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).

Detailed description: The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from both cohorts was pooled for analysis.

Eligibility criteria: Inclusion Criteria:

* Submental fat (SMF) that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the SMF rating scale
* Good general health
* Signed informed consent

Exclusion Criteria:

* History of any treatment in the neck or chin area
* Loose skin or prominent platysmal bands in the neck or chin area
* Recent treatment with anticoagulants
* Presence of clinically significant health problems

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
measure: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
timeFrame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Secondary outcomes:
measure: Change From Baseline in Submental Fat (SMF) Rating Scale Score
timeFrame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
measure: Change From Baseline in Subject Satisfaction With Appearance Rating Scale
timeFrame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
measure: Percentage of Participants With a Response in the Subject Global Improvement Rating
timeFrame: 4 weeks after last treatment (up to 16 weeks after first dose)
measure: Change From Baseline in Skin Laxity Rating
timeFrame: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
measure: Change From Baseline in the Cervicomental Angle
timeFrame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Other outcomes:
Locations:
city: Carina Heights
country: Australia
facility: Investigational Site
city: Gold Coast
country: Australia
facility: Investigational Site
city: Toorak
country: Australia
facility: Investigational Site
city: Oakville
country: Canada
facility: Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: Investigational Site
city: London
country: United Kingdom
facility: Investigational Site
Study officials:
affiliation: Kythera Biopharmaceuticals, Inc.
name: Frederick Beddingfield, MD. PhD
role: STUDY_DIRECTOR
References:
citation: Goodman GJ, Spelman LJ, Lowe N, Bowen B. Randomized, Placebo-Controlled Phase 1/2 Study to Determine the Appropriate ATX-101 Concentration for Reduction of Submental Fat. Dermatol Surg. 2021 Aug 1;47(8):1065-1070. doi: 10.1097/DSS.0000000000003092.