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Trial details imported from ClinicalTrials.gov

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

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

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
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
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
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
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
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
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
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
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
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
Sex
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
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
73
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00618618