Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
ATX-101
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
2 other identifiers
interventional
85
3 countries
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2007
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 8, 2008
CompletedFirst Posted
Study publicly available on registry
February 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
June 15, 2015
CompletedJuly 14, 2015
June 1, 2015
1.2 years
February 8, 2008
May 28, 2015
June 17, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Adverse Events
The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard
From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Secondary Outcomes (5)
Change From Baseline in Submental Fat (SMF) Rating Scale Score
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline in Subject Satisfaction With Appearance Rating Scale
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Percentage of Participants With a Response in the Subject Global Improvement Rating
4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline in Skin Laxity Rating
Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Change From Baseline in the Cervicomental Angle
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Study Arms (4)
Deoxycholic Acid Injection 1 mg/cm²
EXPERIMENTALParticipants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Deoxycholic acid Injection 2 mg/cm²
EXPERIMENTALParticipants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Deoxycholic acid Injection 4 mg/cm²
EXPERIMENTALParticipants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Placebo
PLACEBO COMPARATORParticipants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Investigational Site
Carina Heights, Australia
Investigational Site
Gold Coast, Australia
Investigational Site
Toorak, Australia
Investigational Site
Oakville, Ontario, Canada
Investigational Site
Niagara Falls, Canada
Investigational Site
London, United Kingdom
Related Publications (1)
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.
PMID: 34115682DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Kythera
Study Officials
- STUDY DIRECTOR
Frederick Beddingfield, MD. PhD
Kythera Biopharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2008
First Posted
February 20, 2008
Study Start
August 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
July 14, 2015
Results First Posted
June 15, 2015
Record last verified: 2015-06