Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR)

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

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.

Study Overview

• Status: Completed
• Conditions: Submental Fullness
• Intervention / Treatment: Drug: Deoxycholic acid; Procedure: Surgical Procedures; Procedure: Laser Liposuction; Device: Energy Devices; Other: Other Treatments

• Study Type: Observational
• Enrollment (Actual): 1029

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6E 4M3
      • Pacific Dermaesthetics
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Dr. Shannon Humphrey, Inc.
    • Vancouver, British Columbia, Canada, V6H 1K9
      • Project Skin Vancouver
    • Vancouver, B. C., British Columbia, Canada, V5Z 4E1
      • Dr. Jean Carruthers Cosmetic Surgey Inc.
  • Ontario
    • Toronto, Ontario, Canada, M2K 1E1
      • North York General Hospital
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre
    • Toronto, Ontario, Canada, M5R3N8
      • Sweat clinics of canada
    • Toronto, Ontario, Canada, M4S 2N5
      • Compass Dermatology
    • Woodbridge, Ontario, Canada, L4L 8E2
      • Bertucci MedSpa, Inc.
  • Quebec
    • Montreal, Quebec, Canada, H3S2W1
      • Medime Institut de medecine esthetique
    • Mount Royal, Quebec, Canada, H3R 3A1
      • Dr. Nikolis
• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Skin Spectrum LLC
  • California
    • Beverly Hills, California, United States, 90210
      • John Joseph, MD
    • Beverly Hills, California, United States, 90210
      • The Roxbury Institute
    • Beverly Hills, California, United States, 90212
      • Brian M Kinney, MD Inc
    • Calabasas, California, United States, 91302
      • Bella Skin Institute
    • Danville, California, United States, 94526
      • Jerome R Potozkin MD
    • Fresno, California, United States, 93720
      • Kathleen L Behr
    • Laguna Niguel, California, United States, 92677
      • Ocdermatology Lorrie Klein
    • Los Angeles, California, United States, 90025
      • Westside Aesthetics
    • Los Angeles, California, United States, 90069
      • Skin Care and Laser Physicians of Beverly Hills
    • Newport Beach, California, United States, 92663
      • Batniji Facial Plastic Surgery
    • Newport Beach, California, United States, 92663
      • Steve Yoelin, M.D. Medical Associates, Inc.
    • Pasadena, California, United States, 91105
      • Teleos Plastic Surgery &. Radiance Medical Group Inc
    • Sacramento, California, United States, 95816
      • Laser and Skin Surgery Center of Northern California
    • San Diego, California, United States, 92121
      • Dermatology Cosmetic Laser Medical Associates of La JollaInc
    • San Diego, California, United States, 92121
      • FacesPlus
    • San Diego, California, United States, 92121
      • Goldman Butterwick Fitzpatrick Groff And Fabi Cosmetic Laser
    • San Francisco, California, United States, 94115-1809
      • The Maas Clinic - San Francisco
    • San Francisco, California, United States, 94115
      • Bay Area Cosmetic Dermatology Kathleen M Welsh Md
    • San Francisco, California, United States, 94115
      • Vic A Narurkar MD APC
    • Santa Monica, California, United States, 90404
      • Grossman Dermatology
    • Solana Beach, California, United States, 92075
      • Art of Skin MD
    • Vista, California, United States, 92083
      • Moradi MD
    • Woodside, California, United States, 94062
      • Practice Dr Mary Lynn Moran
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • AboutSkin Dermatology and Dermsurg
  • District of Columbia
    • Washington, District of Columbia, United States, 20005
      • Wa Institute Dermatologic Laser Surg
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Steven Fagien, MD, PA
    • Boca Raton, Florida, United States, 33431
      • Sanctuary Medical Aesthetic Center
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Inc
    • Bradenton, Florida, United States, 34209
      • Susan H Weinkle Md
    • Coral Gables, Florida, United States, 33146-1871
      • Skin Research Institute
    • Miami, Florida, United States, 33173
      • Miami Dermatology and Laser Institute
    • Miami, Florida, United States, 33131
      • The Miami Institute
    • Sarasota, Florida, United States, 34239
      • Center for Sight
    • West Palm Beach, Florida, United States, 33401
      • Research Institute of the Southeast
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Carmen Kavali
    • Atlanta, Georgia, United States, 30328
      • John Connors Plastic Surgery
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Laser & Skin Surgery Center of Indiana
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Coleman Center For Cosmetic Dermatologic Surgery
    • New Orleans, Louisiana, United States, 70124
      • Lupo Center for Aesthetic and General Dermatology
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Facial Plastic Surgical Center
    • Chevy Chase, Maryland, United States, 20815
      • Dermatologic Surgery Center of Washington LLC
    • Glenn Dale, Maryland, United States, 20769
      • Callender Center for Clinical Research, LLC
    • Hunt Valley, Maryland, United States, 21030
      • Maryland Laser Skin & Vein Inst
    • Rockville, Maryland, United States, 20850
      • Lawrence Green MD LLC
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Ranella Hirsch
    • Chestnut Hill, Massachusetts, United States, 02467
      • Skin Care Physicians
    • Wellesley, Massachusetts, United States, 02481
      • Dermatology Partners
  • Michigan
    • Birmingham, Michigan, United States, 48009
      • BOYD
  • Minnesota
    • Edina, Minnesota, United States, 55424
      • United Skin Specialists LTD
  • Missouri
    • Saint Louis, Missouri, United States, 63122
      • Saint Louis University
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, P.C.
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Practice Dr Angela Beckford
    • Montclair, New Jersey, United States, 07042
      • New Jersey Plastic Surgery
    • Montclair, New Jersey, United States, 07042-3439
      • Image Dermatology P.C.
  • New York
    • Forest Hills, New York, United States, 11375
      • Forest Hills Dermatology Group
    • Mount Kisco, New York, United States, 10549
      • The Center for Dermatology Cosmetic and Laser Surgery
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
    • New York, New York, United States, 10075
      • Sadick Research Group
    • New York, New York, United States, 10021
      • Doris Day Pc
    • New York, New York, United States, 10021
      • New York Cosmetic, Skin and Laser Surgery Center (NYC)
    • New York, New York, United States, 10022-3350
      • Juva Skin and Laser Center
    • New York, New York, United States, 10028
      • Marmur Medical
    • New York, New York, United States, 10028
      • New York Laser and Skin Care
    • New York, New York, United States, 10065
      • Luxurgery NYC
    • Smithtown, New York, United States, 11787
      • Marina I Peredo M.D., P.C.
    • West Islip, New York, United States, 11795
      • Mariwalla Dermatology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Finn Facial Plastics
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser & Vein Specialists of the Carolinas
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University Hospital
  • Pennsylvania
    • Ardmore, Pennsylvania, United States, 19003
      • Main Line Center for Laser Surgery
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Plaza Surgical Center
    • Drexel Hill, Pennsylvania, United States, 19026
      • Dermatologic SurgiCenter
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Brian S. Biesman, M.D.
  • Texas
    • Austin, Texas, United States, 78746
      • Westlake Dermatology And Cosmetic Surgery
    • Bellaire, Texas, United States, 77401-3505
      • Bellaire Dermatology Associates (BDA)
    • Plano, Texas, United States, 75093
      • Research Across America
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84101
      • Gateway Aesthetic Institute & Laser Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Hema A Sundaram MDPA
  • Washington
    • Bellevue, Washington, United States, 98004
      • Naficy Plastic Surgery And Rejuvenation Center
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: Deoxycholic acid; Deoxycholic acid (ATX-101) injection as the treatment of SMF as per standard of care in clinical practice.; Other Names: ATX-101; KYBELLA; Procedure: Surgical Procedures; Surgical procedures for treatment of SMF as per standard of care in clinical practice.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Kythera Biopharmaceuticals
• Investigators: Study Director: Rina Patel, MS, CCRA, Allergan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2015
• Primary Completion (Actual): November 10, 2016
• Study Completion (Actual): November 10, 2016

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholagogues and Choleretics; Deoxycholic Acid
• Other Study ID Numbers: CONTOUR