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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00618618




Registration number
NCT00618618
Ethics application status
Date submitted
8/02/2008
Date registered
20/02/2008
Date last updated
14/07/2015

Titles & IDs
Public title
Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Scientific 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
Secondary ID [1] 0 0
2007-006303-21
Secondary ID [2] 0 0
ATX-101-07-07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate or Severe Submental Fullness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Deoxycholic Acid Injection
Treatment: Drugs - Placebo

Experimental: Deoxycholic Acid Injection 0.2 mL/0.7 cm - Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Placebo Comparator: Placebo 0.2 mL/0.7 cm - Participants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Experimental: Deoxycholic Acid Injection 0.2 mL/1.0 cm - Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Placebo Comparator: Placebo 0.2 mL/1.0 cm - Participants received placebo administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Experimental: Deoxycholic Acid Injection 0.4 mL/1.0 cm - Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.

Placebo Comparator: Placebo 0.4 mL/1.0 cm - Participants received placebo administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.


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

Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Primary outcome [2] 0 0
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Timepoint [2] 0 0
From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
4 weeks after last treatment (up to 16 weeks after first dose)
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Secondary outcome [8] 0 0
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)
Timepoint [8] 0 0
Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12

Eligibility
Key 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
Minimum age
25 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational Site - Toorak
Recruitment hospital [2] 0 0
Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
3142 - Toorak
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kythera Biopharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT00618618
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Frederick Beddingfield, III, M.D., Ph.D.
Address 0 0
Kythera Biopharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications