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The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.
This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms.
Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paradigm 1 / Deoxycholic Acid Injection | Experimental | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline CR-SMFRS grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area. |
|
| Paradigm 1/ Placebo | Placebo Comparator | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. |
|
| Paradigm 2 / Deoxycholic Acid Injection | Experimental | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area. |
|
| Paradigm 2 / Placebo | Placebo Comparator | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area. |
|
| Paradigm 3 / Deoxycholic Acid Injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deoxycholic Acid Injection | Drug | Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Visual Analog Scale Scores | Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible). | Baseline and Day 84 |
| Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating). | Baseline (predose) and Day 84 |
| Swelling Grading Scale Scores | The following grading system was used for the assessment of swelling:
| Day 84 |
| Bruising Grading Scale Scores | The following grading system was used for the assessment of bruising:
| Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | 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. A negative change from Baseline indicates improvement. | Baseline and Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Beddingfield, III, MD, PhD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Tempe | Arizona | 85283 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27787269 | Derived | Dover JS, Kenkel JM, Carruthers A, Lizzul PF, Gross TM, Subramanian M, Beddingfield FC 3rd. Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat. Dermatol Surg. 2016 Nov;42 Suppl 1:S288-S299. doi: 10.1097/DSS.0000000000000908. |
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This study was performed at one investigational center in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | Paradigm 1 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline Clinician-Reported Submental Fat Rating Scale [CR-SMFRS] grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area. |
| FG001 | Paradigm 1 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. |
| FG002 | Paradigm 2 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area. |
| FG003 | Paradigm 2 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| FG004 | Paradigm 3 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area. |
| FG005 | Paradigm 3 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| FG006 | Paradigm 4 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| FG007 | Paradigm 4 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Paradigm 1 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. |
| BG001 | Paradigm 1 / Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Pain Visual Analog Scale Scores | Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible). | Safety analysis set with available data at both time points | Posted | Median | Full Range | units on a scale | Baseline and Day 84 |
|
84 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paradigm 1 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (16.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | Kythera | clinical_trials@kythera.com |
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| D017336 | Loratadine |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Experimental |
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area. |
|
| Paradigm 3 / Placebo | Placebo Comparator | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
|
| Paradigm 4 / Deoxycholic Acid Injection | Experimental | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
|
| Paradigm 4 / Placebo | Placebo Comparator | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
|
|
| Placebo | Drug | Phosphate buffered saline placebo for injection |
|
| Cold Compress | Other | A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing. |
|
| Lidocaine / Epinephrine | Drug | Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing. |
|
| Loratadine | Drug | Loratadine 10 mg orally from Day -7 until Day 7 |
|
| Ibuprofen | Drug | Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing. |
|
| Compression Chin Strap | Other | A compression chin strap was applied 15 minutes after dosing for at least 24 hours. |
|
| Induration Grading Scale Scores | The following grading system was used for the assessment of induration:
| Day 84 |
| Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | 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. A negative change from Baseline indicates improvement. | Baseline and Day 84 |
| Change From Baseline in Subject Self Rating Scale (SSRS) | The SSRS assesses participant's 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 Day 84 |
| Change From Baseline in Submental Skin Laxity Grades (SMSLG) | Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement. | Baseline and Day 84 |
| Change From Baseline in Submental Fat Thickness | Submental thickness was measured using caliper devices. | Baseline and Day 84 |
| Patient Experience Questions | Participants were asked to complete 3 patient experience questions, each answered as Yes or No: Given your experience in this study:
The percentage of participants answering Yes on each question is reported. | Day 84 |
| Non-compliance |
|
Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
| BG002 | Paradigm 2 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area. |
| BG003 | Paradigm 2 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| BG004 | Paradigm 3 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area. |
| BG005 | Paradigm 3 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| BG006 | Paradigm 4 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| BG007 | Paradigm 4 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
| Fitzpatrick Skin Type | Fitzpatrick Skin Type is a numerical classification schema for human skin color and typical response to ultraviolet (UV) light:
| Number | participants |
|
| Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | 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. | Number | participants |
|
| Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | 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. | Number | participants |
|
| Subject Self Rating Scale (SSRS) | The SSRS assesses participant's 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. | Number | participants |
|
Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
| OG002 | Paradigm 2 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area. |
| OG003 | Paradigm 2 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| OG004 | Paradigm 3 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area. |
| OG005 | Paradigm 3 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| OG006 | Paradigm 4 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
| OG007 | Paradigm 4 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. |
|
|
|
| Primary | Change From Baseline in Pain Assessment Using McGill Pain Questionnaire | Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating). | Safety analysis set with available data at both time points | Posted | Mean | Standard Deviation | units on a scale | Baseline (predose) and Day 84 |
|
|
|
| Primary | Swelling Grading Scale Scores | The following grading system was used for the assessment of swelling:
| Safety analysis set with available data | Posted | Mean | Standard Deviation | units on a scale | Day 84 |
|
|
|
| Primary | Bruising Grading Scale Scores | The following grading system was used for the assessment of bruising:
| Safety analysis set with available data | Posted | Mean | Standard Deviation | units on a scale | Day 84 |
|
|
|
| Primary | Induration Grading Scale Scores | The following grading system was used for the assessment of induration:
| Safety analysis set with available data | Posted | Mean | Standard Deviation | units on a scale | Day 84 |
|
|
|
| Secondary | Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | 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. A negative change from Baseline indicates improvement. | Safety analysis set with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 84 |
|
|
|
| Secondary | Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | 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. A negative change from Baseline indicates improvement. | Safety analysis set with available data at both time points | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 84 |
|
|
|
| Secondary | Change From Baseline in Subject Self Rating Scale (SSRS) | The SSRS assesses participant's 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. | Safety analysis set with available data at both time points | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 84 |
|
|
|
| Secondary | Change From Baseline in Submental Skin Laxity Grades (SMSLG) | Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement. | Safety analysis set with available data at both time points | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 84 |
|
|
|
| Secondary | Change From Baseline in Submental Fat Thickness | Submental thickness was measured using caliper devices. | Safety analysis set with available data at both time points | Posted | Mean | Standard Deviation | mm | Baseline and Day 84 |
|
|
|
| Secondary | Patient Experience Questions | Participants were asked to complete 3 patient experience questions, each answered as Yes or No: Given your experience in this study:
The percentage of participants answering Yes on each question is reported. | Safety analysis set with available data at each time point | Posted | Number | percentage of participants | Day 84 |
|
|
|
| 0 |
| 17 |
| 17 |
| 17 |
| EG001 | Paradigm 1 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area. | 0 | 3 | 3 | 3 |
| EG002 | Paradigm 2 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area. | 0 | 17 | 17 | 17 |
| EG003 | Paradigm 2 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area. | 0 | 4 | 4 | 4 |
| EG004 | Paradigm 3 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area. | 0 | 16 | 16 | 16 |
| EG005 | Paradigm 3 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. | 0 | 4 | 4 | 4 |
| EG006 | Paradigm 4 / Deoxycholic Acid Injection | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. | 0 | 18 | 18 | 18 |
| EG007 | Paradigm 4 / Placebo | Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area. | 0 | 4 | 4 | 4 |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Application site alopecia | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site anaesthesia | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site dysaesthesia | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
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.
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D002757 | Cholanes |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| Shooting |
|
| Stabbing |
|
| Sharp |
|
| Cramping |
|
| Gnawing |
|
| Hot-Burning |
|
| Aching |
|
| Heavy |
|
| Tender |
|
| Splitting |
|
| Tiring-Exhausting |
|
| Sickening |
|
| Fearful |
|
| Punishing-Cruel |
|
| Present pain |
|
| Receive Additional Treatments |
|
| Normal Activity Affected |
|