Clinical trial NCT02438813: Condition of Submental Fullness and Treatment Outcomes Registry
Official title: CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry (A Registry of Submental Fullness, Treatment Options Administered, and Associated Outcomes)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Submental Fullness
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 1029
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to 19 Months
Secondary outcomes:
measure: Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
timeFrame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment (EOT) Visit (Up to 18 Months)
measure: Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
timeFrame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)
measure: Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
timeFrame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)
measure: Change From Baseline in the Subject Self Rating Scale (SSRS)
timeFrame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)
measure: Change From Baseline in the Patient Self-Perception of Age (SPA)
timeFrame: Baseline (Day 1) to End of Treatment Visit (Up to 18 Months)
measure: Change From Baseline in the Submental Skin Laxity Scale (SMSLG)
timeFrame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Skin Spectrum LLC
state: Arizona
city: Beverly Hills
country: United States
facility: John Joseph, MD
state: California
city: Beverly Hills
country: United States
facility: The Roxbury Institute
state: California
city: Beverly Hills
country: United States
facility: Brian M Kinney, MD Inc
state: California
city: Calabasas
country: United States
facility: Bella Skin Institute
state: California
city: Danville
country: United States
facility: Jerome R Potozkin MD
state: California
city: Fresno
country: United States
facility: Kathleen L Behr
state: California
city: Laguna Niguel
country: United States
facility: Ocdermatology Lorrie Klein
state: California
city: Los Angeles
country: United States
facility: Westside Aesthetics
state: California
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills
state: California
city: Newport Beach
country: United States
facility: Batniji Facial Plastic Surgery
state: California
city: Newport Beach
country: United States
facility: Steve Yoelin, M.D. Medical Associates, Inc.
state: California
city: Pasadena
country: United States
facility: Teleos Plastic Surgery &. Radiance Medical Group Inc
state: California
city: Sacramento
country: United States
facility: Laser And Skin Surgery Center Of Northern California
state: California
city: San Diego
country: United States
facility: Dermatology Cosmetic Laser Medical Associates of La JollaInc
state: California
city: San Diego
country: United States
facility: FacesPlus
state: California
city: San Diego
country: United States
facility: Goldman Butterwick Fitzpatrick Groff And Fabi Cosmetic Laser
state: California
city: San Francisco
country: United States
facility: The Maas Clinic - San Francisco
state: California
city: San Francisco
country: United States
facility: Bay Area Cosmetic Dermatology Kathleen M Welsh Md
state: California
city: San Francisco
country: United States
facility: Vic A Narurkar MD APC
state: California
city: Santa Monica
country: United States
facility: Grossman Dermatology
state: California
city: Solana Beach
country: United States
facility: Art Of Skin MD
state: California
city: Vista
country: United States
facility: Moradi Md
state: California
city: Woodside
country: United States
facility: Practice Dr Mary Lynn Moran
state: California
city: Greenwood Village
country: United States
facility: AboutSkin Dermatology and Dermsurg
state: Colorado
city: Washington
country: United States
facility: Wa Institute Dermatologic Laser Surg
state: District of Columbia
city: Boca Raton
country: United States
facility: Sanctuary Medical Aesthetic Center
state: Florida
city: Boca Raton
country: United States
facility: Steven Fagien, MD, PA
state: Florida
city: Boca Raton
country: United States
facility: Skin Care Research, Inc
state: Florida
city: Bradenton
country: United States
facility: Susan H Weinkle Md
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute
state: Florida
city: Miami
country: United States
facility: The Miami Institute
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Institute
state: Florida
city: Sarasota
country: United States
facility: Center For Sight
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast
state: Florida
city: Atlanta
country: United States
facility: Carmen Kavali
state: Georgia
city: Atlanta
country: United States
facility: John Connors Plastic Surgery
state: Georgia
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Carmel
country: United States
facility: Laser & Skin Surgery Center of Indiana
state: Indiana
city: Metairie
country: United States
facility: Coleman Center For Cosmetic Dermatologic Surgery
state: Louisiana
city: New Orleans
country: United States
facility: Lupo Center for Aesthetic and General Dermatology
state: Louisiana
city: Baltimore
country: United States
facility: Facial Plastic Surgical Center
state: Maryland
city: Chevy Chase
country: United States
facility: Dermatologic Surgery Center of Washington LLC
state: Maryland
city: Glenn Dale
country: United States
facility: Callender Center for Clinical Research, LLC
state: Maryland
city: Hunt Valley
country: United States
facility: Maryland Laser Skin & Vein Inst
state: Maryland
city: Rockville
country: United States
facility: Lawrence Green MD LLC
state: Maryland
city: Cambridge
country: United States
facility: Ranella Hirsch
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
city: Wellesley
country: United States
facility: Dermatology Partners
state: Massachusetts
city: Birmingham
country: United States
facility: Boyd
state: Michigan
city: Edina
country: United States
facility: United Skin Specialists LTD
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, P.C.
state: Nebraska
city: Hackensack
country: United States
facility: Practice Dr Angela Beckford
state: New Jersey
city: Montclair
country: United States
facility: Image Dermatology P.C.
state: New Jersey
city: Montclair
country: United States
facility: New Jersey Plastic Surgery
state: New Jersey
city: Forest Hills
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: Mount Kisco
country: United States
facility: The Center For Dermatology Cosmetic And Laser Surgery
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Doris Day Pc
state: New York
city: New York
country: United States
facility: New York Cosmetic, Skin and Laser Surgery Center (NYC)
state: New York
city: New York
country: United States
facility: JUVA Skin and Laser Center
state: New York
city: New York
country: United States
facility: Marmur Medical
state: New York
city: New York
country: United States
facility: New York Laser and Skin Care
state: New York
city: New York
country: United States
facility: Luxurgery NYC
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Smithtown
country: United States
facility: Marina I Peredo M.D., P.C.
state: New York
city: West Islip
country: United States
facility: Mariwalla Dermatology
state: New York
city: Chapel Hill
country: United States
facility: Finn Facial Plastics
state: North Carolina
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health And Science University Hospital
state: Oregon
city: Ardmore
country: United States
facility: Main Line Center for Laser Surgery
state: Pennsylvania
city: Bala-Cynwyd
country: United States
facility: Plaza Surgical Center
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Dermatologic SurgiCenter
state: Pennsylvania
city: Nashville
country: United States
facility: Brian S. Biesman, M.D.
state: Tennessee
city: Austin
country: United States
facility: Westlake Dermatology And Cosmetic Surgery
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates (BDA)
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Gateway Aesthetic Institute & Laser Center
state: Utah
city: Fairfax
country: United States
facility: Hema A Sundaram MDPA
state: Virginia
city: Bellevue
country: United States
facility: Naficy Plastic Surgery And Rejuvenation Center
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Vancouver, B. C.
country: Canada
facility: Dr. Jean Carruthers Cosmetic Surgey Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. Shannon Humphrey, Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Dermaesthetics
state: British Columbia
city: Vancouver
country: Canada
facility: Project Skin Vancouver
state: British Columbia
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Toronto
country: Canada
facility: Compass Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Sweat Clinics of Canada
state: Ontario
city: Woodbridge
country: Canada
facility: Bertucci MedSpa, Inc.
state: Ontario
city: Montreal
country: Canada
facility: Medime Institut de medecine esthetique
state: Quebec
city: Mount Royal
country: Canada
facility: Dr. Nikolis
state: Quebec
Study officials:
affiliation: Allergan
name: Rina Patel, MS, CCRA
role: STUDY_DIRECTOR
References:
citation: 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.