Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006303-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deoxycholic Acid Injection 0.2 mL/0.7 cm | Experimental | 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 0.2 mL/0.7 cm | Placebo Comparator | 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. |
|
| Deoxycholic Acid Injection 0.2 mL/1.0 cm | Experimental | 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 0.2 mL/1.0 cm | Placebo Comparator | 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. |
|
| Deoxycholic Acid Injection 0.4 mL/1.0 cm | Experimental |
| 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 |
|---|---|---|
| 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:
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:
| From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment). |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frederick Beddingfield, III, M.D., Ph.D. | Kythera Biopharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Toorak | Victoria | 3142 | Australia | ||
| Investigational Site |
Participants were randomized to receive either deoxycholic acid or placebo injection in one of 3 treatment dosing regimens for a total of 6 treatment groups. Placebo participants were pooled for analysis.
This study was conducted at 7 study centers: 4 in Canada, 2 in Australia and 1 in the United Kingdom.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | Pooled Placebo | Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety/Modified Intent-to-Treat (mITT) subset included all randomized participants who received at least 1 dose of study material and who had at least 1 post-baseline observation
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Deoxycholic Acid Injection 0.2 mL/1.0 cm |
| 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 | 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:
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:
| Safety/miTT subset | Posted | Number | participants | From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment). |
|
From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 0.4 mL/1.0 cm | Placebo Comparator | 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. |
|
|
| Placebo | Drug |
|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| Sydney |
| 2000 |
| Australia |
| Investigational Site | Niagara Falls | Ontario | L2E 7H1 | Canada |
| Investigational Site | Oakville | Ontario | L6J 7W5 | Canada |
| Investigational Site | Toronto | Ontario | M4V 1R1 | Canada |
| Investigational Site | Toronto | Ontario | M5S 3B4 | Canada |
| Investigational Site | Manchester | M68HD | United Kingdom |
| Inability to Complete Study Procedures |
|
| Lost to Follow-up |
|
| Non-compliance |
|
| Did Not Meet Entry Criteria |
|
| Death |
|
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. |
| BG002 | 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. |
| BG003 | Pooled Placebo | Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Submental Fat (SMF) Rating | SMF Ratings:
| Number | participants |
|
| Fitzpatrick Skin Type | Fitzpatrick Skin Type is a numerical classification schema for human skin color and typical response to ultraviolet (UV) light:
| Number | participants |
|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | 0Deoxycholic 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. |
| OG003 | Pooled Placebo | Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
|
|
| 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. | Safety/mITT subset with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) |
|
|
|
|
| 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. | Safety/mITT subset with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) |
|
|
|
|
| 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. | Safety/mITT subset with available data | Posted | Number | percentage of participants | 4 weeks after last treatment (up to 16 weeks after first dose) |
|
|
|
|
| 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. | Safety/mITT subset with available data | Posted | Number | percentage of participants | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) |
|
|
|
|
| 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. | Safety/mITT subset | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment) |
|
|
|
|
| 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. | Safety/mITT subset | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment) |
|
|
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Safety/mITT subset | Posted | Number | participants | From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment). |
|
|
|
| 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. | Safety/mITT subset with available data | Posted | Mean | Standard Deviation | degrees | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) |
|
|
|
|
| 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) | Safety/mITT subset with available data at each time point (indicated by "N") | Posted | Mean | Standard Deviation | units on a scale | Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12 |
|
|
|
| 0 |
| 24 |
| 24 |
| 24 |
| EG001 | 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. | 1 | 13 | 13 | 13 |
| EG002 | 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. | 0 | 20 | 20 | 20 |
| EG003 | Pooled Placebo | Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. | 0 | 14 | 14 | 14 |
| Bile Duct Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Anaesthesia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Oedema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Nodule | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Discomfort | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Discolouration | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Haemorrhage | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Papule | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Rash | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Faeces Pale | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hair Growth Abnormal | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Eye Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Vaginal Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Premenstrual Syndrome | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Eye Swelling | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Bruising | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Reaction | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Vesicles | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Injection Site Warmth | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Streptococcal Bacteraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | 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 |
Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate. |
| 0.001 |
| LS Mean Difference |
| -0.9 |
| 2-Sided |
| 95 |
| -1.4 |
| -0.4 |
| No |
| Superiority or Other |
| ANCOVA | Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate. | 0.069 | LS Mean Difference | -0.4 | 2-Sided | 95 | -0.8 | 0.0 | No | Superiority or Other |
Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate. |
| 0.001 |
| LS Mean Difference |
| 2.5 |
| 2-Sided |
| 95 |
| 1.0 |
| 4.0 |
| No |
| Superiority or Other |
| ANCOVA | Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate. | 0.122 | LS Mean Difference | 1.0 | 2-Sided | 95 | -0.3 | 2.2 | No | Superiority or Other |
| Difference from Placebo |
| 32.9 |
| 2-Sided |
| 95 |
| 1.0 |
| 64.8 |
| No |
| Superiority or Other |
| Fisher Exact | 0.252 | Difference from Placebo | 22.9 | 2-Sided | 95 | -8.4 | 54.2 | No | Superiority or Other |
| Difference from Placebo |
| 54.3 |
| 2-Sided |
| 95 |
| 23.0 |
| 85.5 |
| No |
| Superiority or Other |
| Fisher Exact | 0.296 | Difference from Placebo | 24.3 | 2-Sided | 95 | -8.7 | 57.3 | No | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Week 16 |
|
| Week 24 |
|
Week 4
| Repeated Measures |
Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. |
| 0.906 |
| LS Mean Difference |
| 0.0 |
| 2-Sided |
| 95 |
| -0.5 |
| 0.4 |
| No |
| Superiority or Other |
| Week 4 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.404 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.6 | 0.2 | No | Superiority or Other |
| Week 8 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.791 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.5 | 0.3 | No | Superiority or Other |
| Week 8 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.410 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.3 | 0.6 | No | Superiority or Other |
| Week 8 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.733 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.3 | 0.5 | No | Superiority or Other |
| Week 12 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.542 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.3 | 0.5 | No | Superiority or Other |
| Week 12 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.882 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.4 | 0.5 | No | Superiority or Other |
| Week 12 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.934 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.4 | 0.4 | No | Superiority or Other |
| Week 16 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.838 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.4 | 0.4 | No | Superiority or Other |
| Week 16 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.777 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.5 | 0.4 | No | Superiority or Other |
| Week 16 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.795 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.4 | 0.5 | No | Superiority or Other |
| Week 24 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.852 | LS mean Difference | 0.0 | 2-Sided | 95 | -0.4 | 0.4 | No | Superiority or Other |
| Week 24 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.444 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.6 | 0.3 | No | Superiority or Other |
| Week 24 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.724 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.3 | 0.5 | No | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Week 16 |
|
| Week 24 |
|
Week 4
| Repeated Measures |
Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. |
| 0.286 |
| LS Mean Difference |
| -0.2 |
| 2-Sided |
| 95 |
| -0.7 |
| 0.2 |
| No |
| Superiority or Other |
| Week 4 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.190 | LS Mean Difference | 0.3 | 2-Sided | 95 | -0.1 | 0.7 | No | Superiority or Other |
| Week 8 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.402 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.5 | 0.2 | No | Superiority or Other |
| Week 8 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.290 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.7 | 0.2 | No | Superiority or Other |
| Week 8 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.863 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.4 | 0.4 | No | Superiority or Other |
| Week 12 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.128 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.7 | 0.1 | No | Superiority or Other |
| Week 12 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.018 | LS Mean Difference | -0.5 | 2-Sided | 95 | -0.9 | -0.1 | No | Superiority or Other |
| Week 12 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.489 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.5 | 0.3 | No | Superiority or Other |
| Week 16 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.007 | LS Mean Difference | -0.5 | 2-Sided | 95 | -0.9 | -0.1 | No | Superiority or Other |
| Week 16 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | <0.001 | LS Mean Difference | -0.8 | 2-Sided | 95 | -1.3 | -0.4 | No | Superiority or Other |
| Week 16 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.122 | LS Mean Difference | -0.3 | 2-Sided | 95 | -0.7 | 0.1 | No | Superiority or Other |
| Week 24 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.005 | LS Mean Difference | -0.6 | 2-Sided | 95 | -0.9 | -0.2 | No | Superiority or Other |
| Week 24 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | <0.001 | LS Mean Difference | -0.8 | 2-Sided | 95 | -1.2 | -0.3 | No | Superiority or Other |
| Week 24 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.007 | LS Mean Difference | -0.6 | 2-Sided | 95 | -1.0 | -0.2 | No | Superiority or Other |
| Weight |
|
| Vital Signs |
|
| Physical Examinations |
|
Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate. |
| 0.653 |
| LS Mean Difference |
| 1.8 |
| 2-Sided |
| 95 |
| -6.3 |
| 9.9 |
| No |
| Superiority or Other |
| ANCOVA | Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate. | 0.688 | LS Mean Difference | 1.4 | 2-Sided | 95 | -5.4 | 8.1 | No | Superiority or Other |
| Treatment 2 (N=19, 10, 16, 14) |
|
| Treatment 3 (N=17, 10, 16, 13) |
|
| Treatment 4 (N=14, 10, 15, 14) |
|