Clinical trial NCT00618618: Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Official title: Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate or Severe Submental Fullness
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 73
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: Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).


Eligibility criteria: Inclusion Criteria:

* Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (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: Percentage of Participants With an SMF Response
timeFrame: Baseline and 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 to Each Visit in Submental Fat (SMF) Rating Scale Score
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)
measure: Visual Analogue Scale Pain Intensity Rating
timeFrame: Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12
Other outcomes:
Locations:
city: Toorak
country: Australia
facility: Investigational Site
state: Victoria
city: Sydney
country: Australia
facility: Investigational Site
city: Niagara Falls
country: Canada
facility: Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site
state: Ontario
city: Manchester
country: United Kingdom
facility: Investigational Site
Study officials:
affiliation: Kythera Biopharmaceuticals, Inc.
name: Frederick Beddingfield, III, M.D., Ph.D.
role: STUDY_DIRECTOR
References: