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The primary objective of this registry is to develop a comprehensive understanding of the condition of submental (SM) fullness due to submental fat (SMF), how it is treated in current clinical practice, and the risks and benefits associated with its treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled Participants | All enrolled participants who signed informed consent whether or not they elected to receive treatment as per standard of care in clinical practice for submental fat (SMF). Treatments for SMF included: ATX1-101, Surgical Procedures, Laser Liposuction, Energy Devices or Other Treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deoxycholic acid | Drug | Deoxycholic acid (ATX-101) injection as the treatment of SMF as per standard of care in clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | An adverse event is any undesirable medical occurrence or worsening of an existing condition that occurs after SMF reduction treatment, irrespective of whether the event is considered treatment related. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving treatment. | Up to 19 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | The CR-SMFRS is based on the investigator's clinical evaluation of the participant's chin and neck area using a 5-point ordinal scale (0 to 4) with 0=Absent Submental Convexity: no localized submental fat evident; 1=Mild Submental Convexity: minimal, localized submental fat; 2=Moderate Submental Convexity: prominent, localized submental fat; 3=Severe Submental Convexity; a marked amount of chin fat; and 4=Extreme Submental Convexity: marked, localized submental fat. A negative change from Baseline indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients considering treatment to reduce SMF will be recruited from practices that see a large number of aesthetic patients with a variety of issues, including SMF.
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| Name | Affiliation | Role |
|---|---|---|
| Rina Patel, MS, CCRA | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Spectrum LLC | Tucson | Arizona | 85704 | United States | ||
| John Joseph, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30681793 | Derived | Palm MD, Schlessinger J, Callender VD, Fagien S, Beer K, Magante S, Sangha S. Final Data from the Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR). J Drugs Dermatol. 2019 Jan 1;18(1):40-48. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | All enrolled participants who signed informed consent whether or not they elected to receive treatment as per standard of care in clinical practice for submental fat (SMF). Treatments for SMF included: ATX1-101, Surgical Procedures, Laser Liposuction, Energy Devices or Other Treatments. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Surgical Procedures | Procedure | Surgical procedures for treatment of SMF as per standard of care in clinical practice. |
|
| Laser Liposuction | Procedure | Laser Liposuction for the treatment of SMF as per standard of care in clinical practice.. |
|
| Energy Devices | Device | Energy Devices for the treatment of SMF as per standard of care in clinical practice. |
|
| Other Treatments | Other | Other treatments for SMF as per standard of care in clinical practice. |
|
| Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment (EOT) Visit (Up to 18 Months) |
| 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 to 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 (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) |
| Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | 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. | Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) |
| Change From Baseline in the Subject Self Rating Scale (SSRS) | The participant was asked to answer the question: "Considering your appearance in association with your face and chin, how satisfied do you feel with your appearance at the present time?" using a 7-point scale: 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 (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) |
| Change From Baseline in the Patient Self-Perception of Age (SPA) | The participant rated their facial age in years at Baseline and at the End of Treatment Visit by answering the question: How many years difference compare to your actual age? A negative number indicates younger and a positive number indicates older. A negative change from Baseline indicates an improvement. | Baseline (Day 1) to End of Treatment Visit (Up to 18 Months) |
| Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | SMSLG assessment was based on clinical evaluation and palpation of the submental area. The SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Grade 1 (none): no or minimal superficial wrinkling, skin well apposed to deeper neck structures, no skin redundancy [no skin draping or skin sagging]; Grade 2 (mild): mild superficial wrinkling, skin well apposed to deeper neck structures, minimal skin redundancy [slight skin draping and sagging]; Grade 3 (moderate): may have mild to moderate superficial wrinkling, skin has mild to moderate separation from deeper neck structures, moderate skin redundancy [moderate skin draping and skin sagging]; Grade 4 (severe): mild to marked superficial wrinkling, loose skin separated from deeper neck structures, marked skin redundancy [marked skin draping and sagging]. A negative change from Baseline indicates improvement. | Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) |
| Beverly Hills |
| California |
| 90210 |
| United States |
| The Roxbury Institute | Beverly Hills | California | 90210 | United States |
| Brian M Kinney, MD Inc | Beverly Hills | California | 90212 | United States |
| Bella Skin Institute | Calabasas | California | 91302 | United States |
| Jerome R Potozkin MD | Danville | California | 94526 | United States |
| Kathleen L Behr | Fresno | California | 93720 | United States |
| Ocdermatology Lorrie Klein | Laguna Niguel | California | 92677 | United States |
| Westside Aesthetics | Los Angeles | California | 90025 | United States |
| Skin Care and Laser Physicians of Beverly Hills | Los Angeles | California | 90069 | United States |
| Batniji Facial Plastic Surgery | Newport Beach | California | 92663 | United States |
| Steve Yoelin, M.D. Medical Associates, Inc. | Newport Beach | California | 92663 | United States |
| Teleos Plastic Surgery &. Radiance Medical Group Inc | Pasadena | California | 91105 | United States |
| Laser And Skin Surgery Center Of Northern California | Sacramento | California | 95816 | United States |
| Dermatology Cosmetic Laser Medical Associates of La JollaInc | San Diego | California | 92121 | United States |
| FacesPlus | San Diego | California | 92121 | United States |
| Goldman Butterwick Fitzpatrick Groff And Fabi Cosmetic Laser | San Diego | California | 92121 | United States |
| The Maas Clinic - San Francisco | San Francisco | California | 94115-1809 | United States |
| Bay Area Cosmetic Dermatology Kathleen M Welsh Md | San Francisco | California | 94115 | United States |
| Vic A Narurkar MD APC | San Francisco | California | 94115 | United States |
| Grossman Dermatology | Santa Monica | California | 90404 | United States |
| Art Of Skin MD | Solana Beach | California | 92075 | United States |
| Moradi Md | Vista | California | 92083 | United States |
| Practice Dr Mary Lynn Moran | Woodside | California | 94062 | United States |
| AboutSkin Dermatology and Dermsurg | Greenwood Village | Colorado | 80111 | United States |
| Wa Institute Dermatologic Laser Surg | Washington D.C. | District of Columbia | 20005 | United States |
| Sanctuary Medical Aesthetic Center | Boca Raton | Florida | 33431 | United States |
| Steven Fagien, MD, PA | Boca Raton | Florida | 33431 | United States |
| Skin Care Research, Inc | Boca Raton | Florida | 33486 | United States |
| Susan H Weinkle Md | Bradenton | Florida | 34209 | United States |
| Skin Research Institute | Coral Gables | Florida | 33146-1871 | United States |
| The Miami Institute | Miami | Florida | 33131 | United States |
| Miami Dermatology and Laser Institute | Miami | Florida | 33173 | United States |
| Center For Sight | Sarasota | Florida | 34239 | United States |
| Research Institute of the Southeast | West Palm Beach | Florida | 33401 | United States |
| Carmen Kavali | Atlanta | Georgia | 30328 | United States |
| John Connors Plastic Surgery | Atlanta | Georgia | 30328 | United States |
| DeNova Research | Chicago | Illinois | 60611 | United States |
| Laser & Skin Surgery Center of Indiana | Carmel | Indiana | 46032 | United States |
| Coleman Center For Cosmetic Dermatologic Surgery | Metairie | Louisiana | 70006 | United States |
| Lupo Center for Aesthetic and General Dermatology | New Orleans | Louisiana | 70124 | United States |
| Facial Plastic Surgical Center | Baltimore | Maryland | 21208 | United States |
| Dermatologic Surgery Center of Washington LLC | Chevy Chase | Maryland | 20815 | United States |
| Callender Center for Clinical Research, LLC | Glenn Dale | Maryland | 20769 | United States |
| Maryland Laser Skin & Vein Inst | Hunt Valley | Maryland | 21030 | United States |
| Lawrence Green MD LLC | Rockville | Maryland | 20850 | United States |
| Ranella Hirsch | Cambridge | Massachusetts | 02138 | United States |
| Skin Care Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
| Dermatology Partners | Wellesley | Massachusetts | 02481 | United States |
| Boyd | Birmingham | Michigan | 48009 | United States |
| United Skin Specialists LTD | Edina | Minnesota | 55424 | United States |
| Saint Louis University | St Louis | Missouri | 63122 | United States |
| Skin Specialists, P.C. | Omaha | Nebraska | 68144 | United States |
| Practice Dr Angela Beckford | Hackensack | New Jersey | 07601 | United States |
| Image Dermatology P.C. | Montclair | New Jersey | 07042-3439 | United States |
| New Jersey Plastic Surgery | Montclair | New Jersey | 07042 | United States |
| Forest Hills Dermatology Group | Forest Hills | New York | 11375 | United States |
| The Center For Dermatology Cosmetic And Laser Surgery | Mount Kisco | New York | 10549 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Doris Day Pc | New York | New York | 10021 | United States |
| New York Cosmetic, Skin and Laser Surgery Center (NYC) | New York | New York | 10021 | United States |
| JUVA Skin and Laser Center | New York | New York | 10022-3350 | United States |
| Marmur Medical | New York | New York | 10028 | United States |
| New York Laser and Skin Care | New York | New York | 10028 | United States |
| Luxurgery NYC | New York | New York | 10065 | United States |
| Sadick Research Group | New York | New York | 10075 | United States |
| Marina I Peredo M.D., P.C. | Smithtown | New York | 11787 | United States |
| Mariwalla Dermatology | West Islip | New York | 11795 | United States |
| Finn Facial Plastics | Chapel Hill | North Carolina | 27517 | United States |
| Dermatology, Laser & Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| Wilmington Dermatology Center | Wilmington | North Carolina | 28405 | United States |
| Oregon Health And Science University Hospital | Portland | Oregon | 97239 | United States |
| Main Line Center for Laser Surgery | Ardmore | Pennsylvania | 19003 | United States |
| Plaza Surgical Center | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Dermatologic SurgiCenter | Drexel Hill | Pennsylvania | 19026 | United States |
| Brian S. Biesman, M.D. | Nashville | Tennessee | 37203 | United States |
| Westlake Dermatology And Cosmetic Surgery | Austin | Texas | 78746 | United States |
| Bellaire Dermatology Associates (BDA) | Bellaire | Texas | 77401-3505 | United States |
| Research Across America | Plano | Texas | 75093 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Gateway Aesthetic Institute & Laser Center | Salt Lake City | Utah | 84101 | United States |
| Hema A Sundaram MDPA | Fairfax | Virginia | 22031 | United States |
| Naficy Plastic Surgery And Rejuvenation Center | Bellevue | Washington | 98004 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Dr. Shannon Humphrey, Inc. | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Pacific Dermaesthetics | Vancouver | British Columbia | V6E 4M3 | Canada |
| Project Skin Vancouver | Vancouver | British Columbia | V6H 1K9 | Canada |
| Dr. Jean Carruthers Cosmetic Surgey Inc. | Vancouver, B. C. | British Columbia | V5Z 4E1 | Canada |
| North York General Hospital | Toronto | Ontario | M2K 1E1 | Canada |
| Toronto Research Centre | Toronto | Ontario | M3H 5Y8 | Canada |
| Compass Dermatology | Toronto | Ontario | M4S 2N5 | Canada |
| Sweat Clinics of Canada | Toronto | Ontario | M5R3N8 | Canada |
| Bertucci MedSpa, Inc. | Woodbridge | Ontario | L4L 8E2 | Canada |
| Medime Institut de medecine esthetique | Montreal | Quebec | H3S2W1 | Canada |
| Dr. Nikolis | Mount Royal | Quebec | H3R 3A1 | Canada |
| Received Treatment for SMF |
|
| Did Not ReceiveTreatment for SMF |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Enrolled Participants include all participants who signed informed consent whether or not they elected to receive treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants | All enrolled participants who signed informed consent whether or not they elected to receive treatment as per standard of care in clinical practice for submental fat (SMF). Treatments for SMF included: ATX1-101, Surgical Procedures, Laser Liposuction, Energy Devices or Other Treatments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | An adverse event is any undesirable medical occurrence or worsening of an existing condition that occurs after SMF reduction treatment, irrespective of whether the event is considered treatment related. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving treatment. | Safety Population included all participants who received at least one treatment. Participants may have received more than one treatment. | Posted | Number | percentage of participants | Up to 19 Months |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | The CR-SMFRS is based on the investigator's clinical evaluation of the participant's chin and neck area using a 5-point ordinal scale (0 to 4) with 0=Absent Submental Convexity: no localized submental fat evident; 1=Mild Submental Convexity: minimal, localized submental fat; 2=Moderate Submental Convexity: prominent, localized submental fat; 3=Severe Submental Convexity; a marked amount of chin fat; and 4=Extreme Submental Convexity: marked, localized submental fat. A negative change from Baseline indicates improvement. | Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment (EOT) Visit (Up to 18 Months) |
| |||||||||||||||||||||||||||||||||||||||
| 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 to 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. | Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | 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. | Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Subject Self Rating Scale (SSRS) | The participant was asked to answer the question: "Considering your appearance in association with your face and chin, how satisfied do you feel with your appearance at the present time?" using a 7-point scale: 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. | Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Patient Self-Perception of Age (SPA) | The participant rated their facial age in years at Baseline and at the End of Treatment Visit by answering the question: How many years difference compare to your actual age? A negative number indicates younger and a positive number indicates older. A negative change from Baseline indicates an improvement. | Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point. | Posted | Mean | Standard Deviation | years | Baseline (Day 1) to End of Treatment Visit (Up to 18 Months) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Submental Skin Laxity Scale (SMSLG) | SMSLG assessment was based on clinical evaluation and palpation of the submental area. The SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Grade 1 (none): no or minimal superficial wrinkling, skin well apposed to deeper neck structures, no skin redundancy [no skin draping or skin sagging]; Grade 2 (mild): mild superficial wrinkling, skin well apposed to deeper neck structures, minimal skin redundancy [slight skin draping and sagging]; Grade 3 (moderate): may have mild to moderate superficial wrinkling, skin has mild to moderate separation from deeper neck structures, moderate skin redundancy [moderate skin draping and skin sagging]; Grade 4 (severe): mild to marked superficial wrinkling, loose skin separated from deeper neck structures, marked skin redundancy [marked skin draping and sagging]. A negative change from Baseline indicates improvement. | Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) |
|
Up to 19 Months
Safety Population included all participants who received at least one treatment. Participants may have received more than one treatment.
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 (ATX-101) | Deoxycholic acid injection (ATX-101) as treatment for SMF as per standard of care. | 0 | 570 | 75 | 570 | ||
| EG001 | Surgical | Surgical procedures for the treatment of SMF as per standard of care in clinical practice. | 0 | 23 | 2 | 23 | ||
| EG002 | Laser Liposuction | Laser Liposuction for treatment of SMF as per standard of care in clinical practice. | 0 | 5 | 1 | 5 | ||
| EG003 | Energy Devices | Energy Devices as treatment for SMF as per standard of care in clinical practice. | 0 | 77 | 4 | 77 | ||
| EG004 | Other Treatments | Other Treatments for treatment of SMF as per standard of care in clinical practice. | 0 | 9 | 2 | 9 | ||
| EG005 | All Treated Participants | All participants who received treatment for SMF as per standard of care in clinical practice: ATX1-101, Surgical Procedures, Laser Liposuction, Energy Devices or Other Treatments. | 0 | 676 | 81 | 676 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site hypoaesthesia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Application site ulcer | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cutaneous symptom | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site nerve damage | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site scab | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Uncoded | General disorders | MedDRA 18.0 | Systematic Assessment | Uncoded |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
Institution and/or Investigator shall allow Sponsor not less than 45 days to review any manuscript and not less than 30 days to review any poster presentation, abstract or any other written or oral material which describes or discloses the Study results. Institution and Investigator agree that because the Study is part of a multi-center Study, any publication by Institution or Investigator of the Study Results shall not be made before the first multi-center publication of participating sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director/ Epidemiologist | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
Not provided
Not provided
| 51 to 65 years |
|
| >65 years |
|
| Laser Liposuction |
Laser Liposuction for treatment of SMF as per standard of care in clinical practice. |
| OG003 | Energy Devices | Energy Devices as treatment for SMF as per standard of care in clinical practice. |
| OG004 | Other Treatments | Other Treatments for treatment of SMF as per standard of care in clinical practice. |
| OG005 | Not Elected Treatment | All enrolled participants who did not elect to have treatment for SMF. |
|
|
| OG003 | Energy Devices | Energy Devices as treatment for SMF as per standard of care in clinical practice. |
| OG004 | Other Treatments | Other Treatments for treatment of SMF as per standard of care in clinical practice. |
| OG005 | Not Elected Treatment | All enrolled participants who did not elect to have treatment for SMF. |
|
|
| Laser Liposuction |
Laser Liposuction for treatment of SMF as per standard of care in clinical practice. |
| OG003 | Energy Devices | Energy Devices as treatment for SMF as per standard of care in clinical practice. |
| OG004 | Other Treatments | Other Treatments for treatment of SMF as per standard of care in clinical practice. |
| OG005 | Not Elected Treatment | All enrolled participants who did not elect to have treatment for SMF. |
|
|
Laser Liposuction for treatment of SMF as per standard of care in clinical practice.
| OG003 | Energy Devices | Energy Devices as treatment for SMF as per standard of care in clinical practice. |
| OG004 | Other Treatments | Other Treatments for treatment of SMF as per standard of care in clinical practice. |
| OG005 | Not Elected Treatment | All enrolled participants who did not elect to have treatment for SMF. |
|
|
| OG003 |
| Energy Devices |
Energy Devices as treatment for SMF as per standard of care in clinical practice. |
| OG004 | Other Treatments | Other Treatments for treatment of SMF as per standard of care in clinical practice. |
| OG005 | Not Elected Treatment | All enrolled participants who did not elect to have treatment for SMF. |
|
|
| OG001 |
| Surgical |
Surgical procedures for the treatment of SMF as per standard of care in clinical practice. |
| OG002 | Laser Liposuction | Laser Liposuction for treatment of SMF as per standard of care in clinical practice. |
| OG003 | Energy Devices | Energy Devices as treatment for SMF as per standard of care in clinical practice. |
| OG004 | Other Treatments | Other Treatments for treatment of SMF as per standard of care in clinical practice. |
| OG005 | Not Elected Treatment | All enrolled participants who did not elect to have treatment for SMF. |
|
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