Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

• Sponsor: Kythera Biopharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01546142
• Collaborator: (none)
• Enrollment: 516
• Locations: 35
• Arms: 2
• Duration (Months): 17
• Patients Per Site: 14.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Condition or Disease	Intervention/Treatment	Phase
Moderate or Severe Submental Fullness	Drug: Deoxycholic acid injection; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 516 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Drug: Placebo; Phosphate buffered saline placebo for injection
Experimental: Deoxycholic Acid Injection Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Drug: Deoxycholic acid injection; Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Other Names: ATX-101 Kybella

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Achieved a Composite 1-grade Response [Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)]

   A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS 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. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.

2. Percentage of Participants Who Achieved a Composite 2-grade Response [Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)]

   A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS 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. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.

Secondary Outcome Measures

1. Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response [Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)]

   An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.

2. Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) [Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)]

   The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 or 3 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit 1 (within 28 days before randomization).

2. Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit 1 (within 28 days before randomization).

3. Males and nonpregnant, nonlactating females 18 to 65 years of age, inclusive, on the day of randomization (Visit 2). Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before Visit 2 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study. Females of childbearing potential who are not sexually active need not practice contraception.

4. History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization.

5. Expected to understand and agree to comply with the visit schedule and all protocol-specified tests and procedures and agreement by the subject to refrain from making significant changes, in the judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.

6. Agreement to forego any treatment or behavior (e.g., unshaven facial hair) during the subject's participation in the study that may affect the assessments of the submental area.

7. Medically able to undergo the administration of study material determined by clinical and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.

8. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

1. History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents).

2. History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.

3. A Submental Skin Laxity Grade (SMSLG) of 4 or other anatomical feature (e.g., predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands), as assessed within 28 days before randomization, for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome.

4. Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.

5. Body mass index of >40.0 as determined on Visit 1.

6. History or current symptoms of dysphagia.

7. A result on coagulation tests (PT, PTT) obtained within 28 days before randomization that indicates the presence of any clinically significant bleeding disorder.

8. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent.

9. Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization.

10. Treatment with botulinum toxin injections in the neck or chin area within 6 months before randomization.

11. History of sensitivity to any components of the study material

12. History of sensitivity to topical or local anesthetics (e.g., lidocaine, benzocaine, procaine).

13. Previous randomization in this study or previous participation in a Kythera-sponsored ATX 101 trial.

14. Treatment with an investigational device or agent within 30 days before randomization.

15. For centers selected to conduct MRI evaluations, any subject with the presence of any condition that would render a subject unsuitable for MRI evaluation (e.g., claustrophobia), or metals in the body that would interfere with MRI acquisition (e.g., nonremovable metal appliances in the mouth such as silver or gold caps, pacemakers, metal joints).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site	Little Rock	Arkansas	United States	72116
2	Investigational Site	Beverly Hills	California	United States	90210
3	Investigational Site	Los Angeles	California	United States	90067
4	Investigational Site	Sacramento	California	United States	95817
5	Investigational Site	San Francisco	California	United States	94115
6	Investigational Site	Santa Monica	California	United States	90404
7	Investigational Site	Englewood	Colorado	United States	80113
8	Investigational Site	Coral Gables	Florida	United States	33146
9	Investigational Site	Jacksonville	Florida	United States	32204
10	Investigational Site	Chicago	Illinois	United States	60611
11	Investigational Site	Naperville	Illinois	United States	60563
12	Investigational Site	Carmel	Indiana	United States	46032
13	Investigational Site	South Bend	Indiana	United States	46617
14	Investigational Site	Lutherville	Maryland	United States	21093
15	Investigational Site	Clinton Township	Michigan	United States	48038
16	Investigational Site	Edina	Minnesota	United States	55424
17	Investigational Site	St. Louis	Missouri	United States	63141
18	Investigational Site	Montclair	New Jersey	United States	07042
19	Investigational Site	New York	New York	United States	10022
20	Investigational Site	New York	New York	United States	10065
21	Investigational Site	White Plains	New York	United States	10604
22	Investigational Site	Charlotte	North Carolina	United States	28207
23	Investigational Site	High Point	North Carolina	United States	27262
24	Investigational Site	Cincinnatti	Ohio	United States	45255
25	Investigational Site	Portland	Oregon	United States	97035
26	Investigational Site	Austin	Texas	United States	78759
27	Investigational Site	Plano	Texas	United States	75093
28	Investigational Site	San Antonio	Texas	United States	78229
29	Investigational Site	Salt Lake City	Utah	United States	84117
30	Investigational Site	Charlottesville	Virginia	United States	22911
31	Investigational Site	Calgary	Alberta	Canada	T3G0B4
32	Investigational Site	Surrey	British Columbia	Canada	V3R 6A7
33	Investigational Site	Vancouver	British Columbia	Canada	V5Z 4E1
34	Investigational Site	Oakville	Ontario	Canada
35	Investigational Site	Woodbridge	Ontario	Canada	L4L 8E2

Sponsors and Collaborators

• Kythera Biopharmaceuticals

Investigators

• Study Director: Frederick Beddingfield, MD, PhD, Kythera Biopharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kythera Biopharmaceuticals
• ClinicalTrials.gov Identifier: NCT01546142
• Other Study ID Numbers: ATX-101-11-23
• First Posted: Mar 7, 2012
• Last Update Posted: Jun 15, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Deoxycholic Acid

Study Results

Participant Flow

Recruitment Details	The study was performed at 35 investigational centers in the United States (US) and Canada.

Arm/Group Title	Deoxycholic Acid Injection	Placebo
Arm/Group Description	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Period Title: Overall Study
STARTED	258	258
Received Treatment	257	257
COMPLETED	214	224
NOT COMPLETED	44	34

Baseline Characteristics

Arm/Group Title	Deoxycholic Acid Injection	Placebo	Total
Arm/Group Description	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Total of all reporting groups
Overall Participants	258	258	516
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.2 (9.30)	47.6 (8.99)	47.9 (9.14)
Age, Customized (participants) [Number]
18-50 years	149 57.8%	150 58.1%	299 57.9%
51-65 years	109 42.2%	108 41.9%	217 42.1%
Sex: Female, Male (Count of Participants)
Female	221 85.7%	224 86.8%	445 86.2%
Male	37 14.3%	34 13.2%	71 13.8%
Race/Ethnicity, Customized (participants) [Number]
White	222 86%	222 86%	444 86%
Black or African American	24 9.3%	21 8.1%	45 8.7%
Asian	4 1.6%	5 1.9%	9 1.7%
American Indian or Alaskan Native	1 0.4%	2 0.8%	3 0.6%
Native Hawaiian or Pacific Islander	3 1.2%	1 0.4%	4 0.8%
Multiple	2 0.8%	0 0%	2 0.4%
Other	2 0.8%	7 2.7%	9 1.7%
Race/Ethnicity, Customized (participants) [Number]
Hispanic or Latino	40 15.5%	39 15.1%	79 15.3%
Non-Hispanic or Latino	218 84.5%	219 84.9%	437 84.7%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	81.38 (14.791)	80.31 (15.041)	80.84 (14.912)
Body Mass Index (BMI) (kg/m²) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m²]	29.22 (4.755)	29.30 (4.282)	29.26 (4.520)
Fitzpatrick Skin Type (participants) [Number]
I - III	170 65.9%	176 68.2%	346 67.1%
IV - VI	88 34.1%	82 31.8%	170 32.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved a Composite 1-grade Response
Description	A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS 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. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Time Frame	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process.

Arm/Group Title	Deoxycholic Acid Injection	Placebo
Arm/Group Description	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Measure Participants	258	258
Number [percentage of participants]	66.5 25.8%	22.2 8.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Deoxycholic Acid Injection, Placebo
	Comments	The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.983
	Confidence Interval	(2-Sided) 95%; 2.311 to 3.849
	Parameter Dispersion	Type: Value:
	Estimation Comments	A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.

2. Primary Outcome

Title	Percentage of Participants Who Achieved a Composite 2-grade Response
Description	A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment. The CR-SMFRS 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. The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Time Frame	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population; missing values were imputed using a multiple imputation process.

Arm/Group Title	Deoxycholic Acid Injection	Placebo
Arm/Group Description	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Measure Participants	258	258
Number [percentage of participants]	18.6 7.2%	3.0 1.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Deoxycholic Acid Injection, Placebo
	Comments	The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	CMH method stratified by pooled study center.
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	6.271
	Confidence Interval	(2-Sided) 95%; 2.908 to 13.520
	Parameter Dispersion	Type: Value:
	Estimation Comments	A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.

3. Secondary Outcome

Title	Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response
Description	An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.
Time Frame	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)

Outcome Measure Data

Analysis Population Description

The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used.

Arm/Group Title	Deoxycholic Acid Injection	Placebo
Arm/Group Description	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Measure Participants	113	112
Number [percentage of participants]	40.2 15.6%	5.2 2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Deoxycholic Acid Injection, Placebo
	Comments	If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was > 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	CMH method stratified by pooled study center
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	7.838
	Confidence Interval	(2-Sided) 95%; 3.299 to 18.622
	Parameter Dispersion	Type: Value:
	Estimation Comments	A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.

4. Secondary Outcome

Title	Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
Description	The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.
Time Frame	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population; missing values were imputed using a multiple imputation process.

Arm/Group Title	Deoxycholic Acid Injection	Placebo
Arm/Group Description	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Measure Participants	258	258
Mean (Standard Deviation) [units on a scale]	-3.48 (2.692)	-1.42 (2.453)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Deoxycholic Acid Injection, Placebo
	Comments	If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was > 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.

Adverse Events

Time Frame	From the first dose of study drug until 24 weeks after the last dose (up to 44 weeks after first treatment).
Adverse Event Reporting Description	The safety population consisted of all participants who received at least 1 injection of study drug. One participant was randomized to placebo, received deoxycholic acid injection at Visit 4 (Week 8), and was included in the deoxycholic acid injection arm for safety analyses.
Arm/Group Title	Deoxycholic Acid Injection		Placebo
Arm/Group Description	Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.		Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
All Cause Mortality
	Deoxycholic Acid Injection		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Deoxycholic Acid Injection		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/258 (2.7%)		10/256 (3.9%)
Cardiac disorders
Cardiac failure congestive	0/258 (0%)		1/256 (0.4%)
Gastrointestinal disorders
Gastrooesophageal reflux disease	1/258 (0.4%)		0/256 (0%)
Pancreatitis	0/258 (0%)		1/256 (0.4%)
Infections and infestations
Diverticulitis	0/258 (0%)		1/256 (0.4%)
Influenza	0/258 (0%)		1/256 (0.4%)
Spinal cord infection	0/258 (0%)		1/256 (0.4%)
Urinary tract infection	1/258 (0.4%)		0/256 (0%)
Injury, poisoning and procedural complications
Road traffic accident	1/258 (0.4%)		0/256 (0%)
Toxicity to various agents	0/258 (0%)		1/256 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/258 (0%)		1/256 (0.4%)
Breast cancer recurrent	1/258 (0.4%)		0/256 (0%)
Ovarian cancer	1/258 (0.4%)		0/256 (0%)
Uterine cancer	1/258 (0.4%)		0/256 (0%)
Uterine leiomyoma	1/258 (0.4%)		0/256 (0%)
Nervous system disorders
Transient ischaemic attack	0/258 (0%)		1/256 (0.4%)
Reproductive system and breast disorders
Cystocele	1/258 (0.4%)		0/256 (0%)
Rectocele	1/258 (0.4%)		0/256 (0%)
Uterine prolapse	1/258 (0.4%)		0/256 (0%)
Surgical and medical procedures
Hip surgery	0/258 (0%)		1/256 (0.4%)
Intervertebral disc operation	1/258 (0.4%)		0/256 (0%)
Vaginal operation	0/258 (0%)		1/256 (0.4%)
Other (Not Including Serious) Adverse Events
	Deoxycholic Acid Injection		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	251/258 (97.3%)		216/256 (84.4%)
General disorders
Injection site haematoma	188/258 (72.9%)		186/256 (72.7%)
Injection site pain	190/258 (73.6%)		100/256 (39.1%)
Injection site oedema	175/258 (67.8%)		93/256 (36.3%)
Injection site anaesthesia	169/258 (65.5%)		18/256 (7%)
Injection site erythema	91/258 (35.3%)		65/256 (25.4%)
Injection site swelling	75/258 (29.1%)		40/256 (15.6%)
Injection site induration	73/258 (28.3%)		9/256 (3.5%)
Injection site pruritus	42/258 (16.3%)		21/256 (8.2%)
Injection site paraesthesia	38/258 (14.7%)		11/256 (4.3%)
Injection site nodule	37/258 (14.3%)		11/256 (4.3%)
Injection site warmth	15/258 (5.8%)		6/256 (2.3%)
Infections and infestations
Upper respiratory tract infection	15/258 (5.8%)		18/256 (7%)
Nasopharyngitis	12/258 (4.7%)		13/256 (5.1%)
Nervous system disorders
Headache	23/258 (8.9%)		8/256 (3.1%)
Skin and subcutaneous tissue disorders
Skin tightness	19/258 (7.4%)		5/256 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Clinical Study Agreement requires that the investigator or institution obtain written consent from Kythera prior to presenting and/or publishing results of this study.