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The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.
A lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deoxycholic Acid 1% | Experimental | Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
|
| Deoxycholic Acid 2% | Experimental | Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
|
| Deoxycholic Acid 4% | Experimental | Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
|
| Placebo | Placebo Comparator | Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deoxycholic Acid Injection | Drug | Administered via intralipomal injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard. | Up to 24 weeks |
| Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | An abnormality is defined as a value outside the limits of the expanded normal range/notable range. | 24 weeks |
| Number of Participants With Clinically Significant Changes in Vital Signs or Weight | Up to 24 weeks | |
| Number of Participants With Positive Histopathology Results at Screening | A needle core tissue sample biopsy was performed at screening for all treated lipomas. | Screening (prior to randomization) |
| Number of Participants With Positive Histopathology Results at Week 20 | After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Clearance or ≥ 75% Clearance | At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers. Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s). For participants with > 1 target lipoma, the total area of all target lipomas was used in the calculation of response. |
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Inclusion Criteria:
One or more lipomas, based on clinical and histological diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:
Signed informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia S. Walker, M.D., Ph.D. | Kythera Biopharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gary D. Monheit, M.D. | Birmingham | Alabama | 35205 | United States | ||
| Stacy R. Smith |
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| ID | Title | Description |
|---|---|---|
| FG000 | Deoxycholic Acid 1% | Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| FG001 | Deoxycholic Acid 2% | Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| FG002 | Deoxycholic Acid 4% | Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| FG003 | Placebo | Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Modified intent-to-treat (MITT) population included all randomized participants who had received at least 1 dose of study material and who had at least 1 postbaseline observation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Deoxycholic Acid 1% | Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| BG001 | Deoxycholic Acid 2% |
| 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 (AEs) | Severity of AEs was determined using the following scale: Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: "Was there a reasonable possibility that the event may have been caused by treatment with study material?" A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator's or sponsor's opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard. | Safety population (all participants who received at least 1 dose of study medication) | Posted | Number | participants | Up to 24 weeks |
|
24 weeks
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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 | Deoxycholic Acid 1% | Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patella Fracture | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Erythema | General disorders | MedDRA 10 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | Kythera Biopharmaceuticals, Inc. | clinical_trials@kythera.com |
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| ID | Term |
|---|---|
| D008067 | Lipoma |
| ID | Term |
|---|---|
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Placebo | Drug | Matching vehicle placebo administered via intralipomal injection. |
|
| Week 20 |
| Baseline and week 20 (8 weeks after last dose) |
| Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area * 100. A positive change indicates a reduction in size. | Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment) |
| San Diego |
| California |
| 92123 |
| United States |
| Steven Grekin, D.O. | Warren | Michigan | 48088 | United States |
| Joel Schlessinger, M.D. | Omaha | Nebraska | 68144 | United States |
| David J. Goldberg, M.D. | Westwood | New Jersey | 07675 | United States |
| Neil S. Sadick, M.D. | New York | New York | 10021 | United States |
| Michael H. Gold, M.D. | Nashville | Tennessee | 37215 | United States |
| Lost to Follow-up |
|
Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| BG002 | Deoxycholic Acid 4% | Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| BG003 | Placebo | Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Deoxycholic Acid 1% | Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| OG001 | Deoxycholic Acid 2% | Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| OG002 | Deoxycholic Acid 4% | Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
| OG003 | Placebo | Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. |
|
|
| Secondary | Percentage of Participants With Complete Clearance or ≥ 75% Clearance | At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers. Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s). For participants with > 1 target lipoma, the total area of all target lipomas was used in the calculation of response. | MITT Population | Posted | Number | percentage of participants | Baseline and week 20 (8 weeks after last dose) |
|
|
|
|
| Primary | Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities | An abnormality is defined as a value outside the limits of the expanded normal range/notable range. | Safety population | Posted | Number | participants | 24 weeks |
|
|
|
| Secondary | Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas | Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area * 100. A positive change indicates a reduction in size. | MITT Population | Posted | Mean | Standard Deviation | percent change | Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment) |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs or Weight | Safety population | Posted | Number | participants | Up to 24 weeks |
|
|
|
| Primary | Number of Participants With Positive Histopathology Results at Screening | A needle core tissue sample biopsy was performed at screening for all treated lipomas. | Safety population with biopsy results at screening | Posted | Number | participants | Screening (prior to randomization) |
|
|
|
| Primary | Number of Participants With Positive Histopathology Results at Week 20 | After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised. | Safety population with biopsy results at week 20 | Posted | Number | participants | Week 20 |
|
|
|
| 1 |
| 15 |
| 12 |
| 15 |
| EG001 | Deoxycholic Acid 2% | Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. | 0 | 15 | 13 | 15 |
| EG002 | Deoxycholic Acid 4% | Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. | 1 | 15 | 14 | 15 |
| EG003 | Placebo | Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. | 0 | 17 | 12 | 17 |
| Tibia Fracture | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Breast Cancer | Reproductive system and breast disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Bruising | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Anaesthesia | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Discolouration | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Irritation | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Ulcer | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Discharge | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Haemorrhage | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Desquamation | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Inflammation | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Rash | General disorders | MedDRA 10 | Systematic Assessment |
|
| Injection Site Warmth | General disorders | MedDRA 10 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Tinea Infection | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Vaginitis Bacterial | Infections and infestations | MedDRA 10 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Muscle Strain | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Jaundice | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Skin Infection | Skin and subcutaneous tissue disorders | MedDRA 10 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10 | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA 10 | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 10 | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA 10 | Systematic Assessment |
|
| Blood Cholesterol Increased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Blood Triglycerides Increased | Investigations | MedDRA 10 | Systematic Assessment |
|
| Liver Function Test Abnormal | Investigations | MedDRA 10 | Systematic Assessment |
|
| Urine Colour Abnormal | Investigations | MedDRA 10 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 10 | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA 10 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 10 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 10 | Systematic Assessment |
|
| Hepatitis C | Hepatobiliary disorders | MedDRA 10 | Systematic Assessment |
|
The clinical study agreement requires that the investigator or institution obtain written consent from Kythera Biopharmaceuticals, Inc. prior to presenting and/or publishing results of this study.
| D011083 |
| Polycyclic Compounds |
| D002757 | Cholanes |
| ≥ 75% Cleared |
|
| Difference to placebo |
| 0.0 |
| 2-Sided |
| 95 |
| -18.4 |
| 20.4 |
| No |
| Superiority or Other |
| Complete Clearance | Difference to placebo | 7.1 | 2-Sided | 95 | -12.2 | 31.5 | No | Superiority or Other |
| ≥ 75% Cleared | Difference to placebo | 1.6 | 2-Sided | 95 | -23.0 | 27.5 | No | Superiority or Other |
| ≥ 75% Cleared | Difference to placebo | -5.1 | 2-Sided | 95 | -28.3 | 19.6 | No | Superiority or Other |
| ≥ 75% Cleared | Difference to placebo | 2.5 | 2-Sided | 95 | -22.3 | 29.5 | No | Superiority or Other |
| Alanine transaminase |
|
| Aspartate aminotransferase |
|
| Alkaline phosphatase |
|
| Urinalysis - Glucose |
|
| Week 16 |
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| Week 20 |
|
| Chronic inflammation |
|
| Fibrosis/scarring |
|
| Hemorrhage |
|
| Mature adipose tissue |
|
| Necrosis |
|
| Chronic inflammation |
|
| Fibrosis/scarring |
|
| Hemorrhage |
|
| Mature adipose tissue |
|
| Necrosis |
|