Condition of Submental Fullness and Treatment Outcomes Registry

Submental Fullness Clinical Trial

— CONTOUR  

Official title:

CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry (A Registry of Submental Fullness, Treatment Options Administered, and Associated Outcomes)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438813
• Other study ID #: CONTOUR
• Status: Completed
• Start date: May 11, 2015
• Est. completion date: November 10, 2016

Study information

• Verified date: October 2018
• Source: Kythera Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1029
• Est. completion date: November 10, 2016
• Est. primary completion date: November 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult male and female patients, aged 18 years and above, presenting with SM fullness due to the accumulation of unwanted SMF, and considered by their treating physician to be a candidate to receive treatment of SM fullness by reduction of SMF, if the patient decides

• Signed informed consent by the patient, obtained before any study-related activities are undertaken

• Willing to complete all patient assessment questionnaires

• Signed release form by the patient, permitting abstraction of the patient's medical records at baseline and during participation in the registry

Exclusion Criteria:

• Severe skin laxity, defined as superficial wrinkling, loose skin separated from deeper neck structures, and/or marked skin redundancy (draping and/or sagging), per the physician's judgment

• Any other cause of fullness in the SM area (eg, thyroid enlargement, cervical adenopathy) other than localized SMF

• Participating in an interventional clinical study, currently or within 30 days before enrollment

Related Conditions & MeSH terms

• Submental Fullness

Intervention

Drug:
• Deoxycholic acid
Deoxycholic acid (ATX-101) injection as the treatment of SMF as per standard of care in clinical practice.

Procedure:
• Surgical Procedures
Surgical procedures for treatment of SMF as per standard of care in clinical practice.
• Laser Liposuction
Laser Liposuction for the treatment of SMF as per standard of care in clinical practice..

Device:
• Energy Devices
Energy Devices for the treatment of SMF as per standard of care in clinical practice.

Other:
• Other Treatments
Other treatments for SMF as per standard of care in clinical practice.

Locations

Country	Name	City	State
Canada	Medime Institut de medecine esthetique	Montreal	Quebec
Canada	Dr. Nikolis	Mount Royal	Quebec
Canada	Compass Dermatology	Toronto	Ontario
Canada	North York General Hospital	Toronto	Ontario
Canada	Sweat Clinics of Canada	Toronto	Ontario
Canada	Toronto Research Centre	Toronto	Ontario
Canada	Dr. Shannon Humphrey, Inc.	Vancouver	British Columbia
Canada	Pacific Dermaesthetics	Vancouver	British Columbia
Canada	Project Skin Vancouver	Vancouver	British Columbia
Canada	Dr. Jean Carruthers Cosmetic Surgey Inc.	Vancouver, B. C.	British Columbia
Canada	Bertucci MedSpa, Inc.	Woodbridge	Ontario
United States	Main Line Center for Laser Surgery	Ardmore	Pennsylvania
United States	Carmen Kavali	Atlanta	Georgia
United States	John Connors Plastic Surgery	Atlanta	Georgia
United States	Westlake Dermatology And Cosmetic Surgery	Austin	Texas
United States	Plaza Surgical Center	Bala-Cynwyd	Pennsylvania
United States	Facial Plastic Surgical Center	Baltimore	Maryland
United States	Bellaire Dermatology Associates (BDA)	Bellaire	Texas
United States	Naficy Plastic Surgery And Rejuvenation Center	Bellevue	Washington
United States	Brian M Kinney, MD Inc	Beverly Hills	California
United States	John Joseph, MD	Beverly Hills	California
United States	The Roxbury Institute	Beverly Hills	California
United States	Boyd	Birmingham	Michigan
United States	Sanctuary Medical Aesthetic Center	Boca Raton	Florida
United States	Skin Care Research, Inc	Boca Raton	Florida
United States	Steven Fagien, MD, PA	Boca Raton	Florida
United States	Susan H Weinkle Md	Bradenton	Florida
United States	Bella Skin Institute	Calabasas	California
United States	Ranella Hirsch	Cambridge	Massachusetts
United States	Laser & Skin Surgery Center of Indiana	Carmel	Indiana
United States	Finn Facial Plastics	Chapel Hill	North Carolina
United States	Dermatology, Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	Skin Care Physicians	Chestnut Hill	Massachusetts
United States	Dermatologic Surgery Center of Washington LLC	Chevy Chase	Maryland
United States	DeNova Research	Chicago	Illinois
United States	Skin Research Institute	Coral Gables	Florida
United States	Jerome R Potozkin MD	Danville	California
United States	Dermatologic SurgiCenter	Drexel Hill	Pennsylvania
United States	United Skin Specialists LTD	Edina	Minnesota
United States	Hema A Sundaram MDPA	Fairfax	Virginia
United States	Forest Hills Dermatology Group	Forest Hills	New York
United States	Kathleen L Behr	Fresno	California
United States	Callender Center for Clinical Research, LLC	Glenn Dale	Maryland
United States	AboutSkin Dermatology and Dermsurg	Greenwood Village	Colorado
United States	Practice Dr Angela Beckford	Hackensack	New Jersey
United States	Maryland Laser Skin & Vein Inst	Hunt Valley	Maryland
United States	Ocdermatology Lorrie Klein	Laguna Niguel	California
United States	Skin Care and Laser Physicians of Beverly Hills	Los Angeles	California
United States	Westside Aesthetics	Los Angeles	California
United States	Coleman Center For Cosmetic Dermatologic Surgery	Metairie	Louisiana
United States	Miami Dermatology and Laser Institute	Miami	Florida
United States	The Miami Institute	Miami	Florida
United States	Image Dermatology P.C.	Montclair	New Jersey
United States	New Jersey Plastic Surgery	Montclair	New Jersey
United States	The Center For Dermatology Cosmetic And Laser Surgery	Mount Kisco	New York
United States	Brian S. Biesman, M.D.	Nashville	Tennessee
United States	Lupo Center for Aesthetic and General Dermatology	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Doris Day Pc	New York	New York
United States	JUVA Skin and Laser Center	New York	New York
United States	Luxurgery NYC	New York	New York
United States	Marmur Medical	New York	New York
United States	New York Cosmetic, Skin and Laser Surgery Center (NYC)	New York	New York
United States	New York Laser and Skin Care	New York	New York
United States	Sadick Research Group	New York	New York
United States	Batniji Facial Plastic Surgery	Newport Beach	California
United States	Steve Yoelin, M.D. Medical Associates, Inc.	Newport Beach	California
United States	Skin Specialists, P.C.	Omaha	Nebraska
United States	Teleos Plastic Surgery &. Radiance Medical Group Inc	Pasadena	California
United States	Research Across America	Plano	Texas
United States	Oregon Health And Science University Hospital	Portland	Oregon
United States	Lawrence Green MD LLC	Rockville	Maryland
United States	Laser And Skin Surgery Center Of Northern California	Sacramento	California
United States	Saint Louis University	Saint Louis	Missouri
United States	Gateway Aesthetic Institute & Laser Center	Salt Lake City	Utah
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Dermatology Cosmetic Laser Medical Associates of La JollaInc	San Diego	California
United States	FacesPlus	San Diego	California
United States	Goldman Butterwick Fitzpatrick Groff And Fabi Cosmetic Laser	San Diego	California
United States	Bay Area Cosmetic Dermatology Kathleen M Welsh Md	San Francisco	California
United States	The Maas Clinic - San Francisco	San Francisco	California
United States	Vic A Narurkar MD APC	San Francisco	California
United States	Grossman Dermatology	Santa Monica	California
United States	Center For Sight	Sarasota	Florida
United States	Marina I Peredo M.D., P.C.	Smithtown	New York
United States	Art Of Skin MD	Solana Beach	California
United States	Premier Clinical Research	Spokane	Washington
United States	Skin Spectrum LLC	Tucson	Arizona
United States	Moradi Md	Vista	California
United States	Wa Institute Dermatologic Laser Surg	Washington	District of Columbia
United States	Dermatology Partners	Wellesley	Massachusetts
United States	Mariwalla Dermatology	West Islip	New York
United States	Research Institute of the Southeast	West Palm Beach	Florida
United States	Wilmington Dermatology Center	Wilmington	North Carolina
United States	Practice Dr Mary Lynn Moran	Woodside	California

Sponsors (1)

Lead Sponsor	Collaborator
Kythera Biopharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	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.	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.	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.	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.	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.	Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)