Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

Moderate or Severe Submental Fullness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618618
• Other study ID #: ATX-101-07-07
• Secondary ID: 2007-006303-21
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2008
• Last updated: June 17, 2015
• Start date: April 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2015
• Source: Kythera Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moderate or Severe Submental Fullness

Intervention

Drug:
• Deoxycholic Acid Injection
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
• Placebo

Locations

Country	Name	City	State
Australia	Investigational Site	Sydney
Australia	Investigational Site	Toorak	Victoria
Canada	Investigational Site	Niagara Falls	Ontario
Canada	Investigational Site	Oakville	Ontario
Canada	Investigational Site	Toronto	Ontario
Canada	Investigational Site	Toronto	Ontario
United Kingdom	Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Countries where clinical trial is conducted

Australia,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Primary	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).	No
Secondary	Change From Baseline in Submental Fat (SMF) Rating Scale Score	The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.; A negative change from Baseline indicates improvement.	Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)	No
Secondary	Change From Baseline in Subject Satisfaction With Appearance Rating Scale	The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.; A positive change from Baseline indicates improvement.	Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)	No
Secondary	Percentage of Participants With a Response in the Subject Global Improvement Rating	Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.; 0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.; Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6.	4 weeks after last treatment (up to 16 weeks after first dose)	No
Secondary	Percentage of Participants With an SMF Response	Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.	Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)	No
Secondary	Change From Baseline in Skin Laxity Rating	Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement.	Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)	No
Secondary	Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score	The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.; A negative change from Baseline indicates improvement.	Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)	No
Secondary	Change From Baseline in the Cervicomental Angle	The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.	Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)	No
Secondary	Visual Analogue Scale Pain Intensity Rating	Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)	Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12	No