Condition of Submental Fullness and Treatment Outcomes Registry

NCT ID: NCT02438813

Last Updated: 2018-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1029 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-11

Study Completion Date

2016-11-10

Brief Summary

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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.

Detailed Description

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Conditions

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Submental Fullness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Deoxycholic acid

Intervention Type DRUG

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

Surgical Procedures

Intervention Type PROCEDURE

Surgical procedures for treatment of SMF as per standard of care in clinical practice.

Laser Liposuction

Intervention Type PROCEDURE

Laser Liposuction for the treatment of SMF as per standard of care in clinical practice..

Energy Devices

Intervention Type DEVICE

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

Other Treatments

Intervention Type OTHER

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

Interventions

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Deoxycholic acid

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

Intervention Type DRUG

Surgical Procedures

Surgical procedures for treatment of SMF as per standard of care in clinical practice.

Intervention Type PROCEDURE

Laser Liposuction

Laser Liposuction for the treatment of SMF as per standard of care in clinical practice..

Intervention Type PROCEDURE

Energy Devices

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

Intervention Type DEVICE

Other Treatments

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

Intervention Type OTHER

Other Intervention Names

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ATX-101 KYBELLA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kythera Biopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rina Patel, MS, CCRA

Role: STUDY_DIRECTOR

Allergan

Locations

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Skin Spectrum LLC

Tucson, Arizona, United States

Site Status

John Joseph, MD

Beverly Hills, California, United States

Site Status

The Roxbury Institute

Beverly Hills, California, United States

Site Status

Brian M Kinney, MD Inc

Beverly Hills, California, United States

Site Status

Bella Skin Institute

Calabasas, California, United States

Site Status

Jerome R Potozkin MD

Danville, California, United States

Site Status

Kathleen L Behr

Fresno, California, United States

Site Status

Ocdermatology Lorrie Klein

Laguna Niguel, California, United States

Site Status

Westside Aesthetics

Los Angeles, California, United States

Site Status

Skin Care and Laser Physicians of Beverly Hills

Los Angeles, California, United States

Site Status

Batniji Facial Plastic Surgery

Newport Beach, California, United States

Site Status

Steve Yoelin, M.D. Medical Associates, Inc.

Newport Beach, California, United States

Site Status

Teleos Plastic Surgery &. Radiance Medical Group Inc

Pasadena, California, United States

Site Status

Laser And Skin Surgery Center Of Northern California

Sacramento, California, United States

Site Status

Dermatology Cosmetic Laser Medical Associates of La JollaInc

San Diego, California, United States

Site Status

FacesPlus

San Diego, California, United States

Site Status

Goldman Butterwick Fitzpatrick Groff And Fabi Cosmetic Laser

San Diego, California, United States

Site Status

The Maas Clinic - San Francisco

San Francisco, California, United States

Site Status

Bay Area Cosmetic Dermatology Kathleen M Welsh Md

San Francisco, California, United States

Site Status

Vic A Narurkar MD APC

San Francisco, California, United States

Site Status

Grossman Dermatology

Santa Monica, California, United States

Site Status

Art Of Skin MD

Solana Beach, California, United States

Site Status

Moradi Md

Vista, California, United States

Site Status

Practice Dr Mary Lynn Moran

Woodside, California, United States

Site Status

AboutSkin Dermatology and Dermsurg

Greenwood Village, Colorado, United States

Site Status

Wa Institute Dermatologic Laser Surg

Washington D.C., District of Columbia, United States

Site Status

Sanctuary Medical Aesthetic Center

Boca Raton, Florida, United States

Site Status

Steven Fagien, MD, PA

Boca Raton, Florida, United States

Site Status

Skin Care Research, Inc

Boca Raton, Florida, United States

Site Status

Susan H Weinkle Md

Bradenton, Florida, United States

Site Status

Skin Research Institute

Coral Gables, Florida, United States

Site Status

The Miami Institute

Miami, Florida, United States

Site Status

Miami Dermatology and Laser Institute

Miami, Florida, United States

Site Status

Center For Sight

Sarasota, Florida, United States

Site Status

Research Institute of the Southeast

West Palm Beach, Florida, United States

Site Status

Carmen Kavali

Atlanta, Georgia, United States

Site Status

John Connors Plastic Surgery

Atlanta, Georgia, United States

Site Status

DeNova Research

Chicago, Illinois, United States

Site Status

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, United States

Site Status

Coleman Center For Cosmetic Dermatologic Surgery

Metairie, Louisiana, United States

Site Status

Lupo Center for Aesthetic and General Dermatology

New Orleans, Louisiana, United States

Site Status

Facial Plastic Surgical Center

Baltimore, Maryland, United States

Site Status

Dermatologic Surgery Center of Washington LLC

Chevy Chase, Maryland, United States

Site Status

Callender Center for Clinical Research, LLC

Glenn Dale, Maryland, United States

Site Status

Maryland Laser Skin & Vein Inst

Hunt Valley, Maryland, United States

Site Status

Lawrence Green MD LLC

Rockville, Maryland, United States

Site Status

Ranella Hirsch

Cambridge, Massachusetts, United States

Site Status

Skin Care Physicians

Chestnut Hill, Massachusetts, United States

Site Status

Dermatology Partners

Wellesley, Massachusetts, United States

Site Status

Boyd

Birmingham, Michigan, United States

Site Status

United Skin Specialists LTD

Edina, Minnesota, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

Skin Specialists, P.C.

Omaha, Nebraska, United States

Site Status

Practice Dr Angela Beckford

Hackensack, New Jersey, United States

Site Status

Image Dermatology P.C.

Montclair, New Jersey, United States

Site Status

New Jersey Plastic Surgery

Montclair, New Jersey, United States

Site Status

Forest Hills Dermatology Group

Forest Hills, New York, United States

Site Status

The Center For Dermatology Cosmetic And Laser Surgery

Mount Kisco, New York, United States

Site Status

Beth Israel Medical Center

New York, New York, United States

Site Status

Doris Day Pc

New York, New York, United States

Site Status

New York Cosmetic, Skin and Laser Surgery Center (NYC)

New York, New York, United States

Site Status

JUVA Skin and Laser Center

New York, New York, United States

Site Status

Marmur Medical

New York, New York, United States

Site Status

New York Laser and Skin Care

New York, New York, United States

Site Status

Luxurgery NYC

New York, New York, United States

Site Status

Sadick Research Group

New York, New York, United States

Site Status

Marina I Peredo M.D., P.C.

Smithtown, New York, United States

Site Status

Mariwalla Dermatology

West Islip, New York, United States

Site Status

Finn Facial Plastics

Chapel Hill, North Carolina, United States

Site Status

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, United States

Site Status

Wilmington Dermatology Center

Wilmington, North Carolina, United States

Site Status

Oregon Health And Science University Hospital

Portland, Oregon, United States

Site Status

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, United States

Site Status

Plaza Surgical Center

Bala-Cynwyd, Pennsylvania, United States

Site Status

Dermatologic SurgiCenter

Drexel Hill, Pennsylvania, United States

Site Status

Brian S. Biesman, M.D.

Nashville, Tennessee, United States

Site Status

Westlake Dermatology And Cosmetic Surgery

Austin, Texas, United States

Site Status

Bellaire Dermatology Associates (BDA)

Bellaire, Texas, United States

Site Status

Research Across America

Plano, Texas, United States

Site Status

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Site Status

Gateway Aesthetic Institute & Laser Center

Salt Lake City, Utah, United States

Site Status

Hema A Sundaram MDPA

Fairfax, Virginia, United States

Site Status

Naficy Plastic Surgery And Rejuvenation Center

Bellevue, Washington, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

Dr. Shannon Humphrey, Inc.

Vancouver, British Columbia, Canada

Site Status

Pacific Dermaesthetics

Vancouver, British Columbia, Canada

Site Status

Project Skin Vancouver

Vancouver, British Columbia, Canada

Site Status

Dr. Jean Carruthers Cosmetic Surgey Inc.

Vancouver, B. C., British Columbia, Canada

Site Status

North York General Hospital

Toronto, Ontario, Canada

Site Status

Toronto Research Centre

Toronto, Ontario, Canada

Site Status

Compass Dermatology

Toronto, Ontario, Canada

Site Status

Sweat Clinics of Canada

Toronto, Ontario, Canada

Site Status

Bertucci MedSpa, Inc.

Woodbridge, Ontario, Canada

Site Status

Medime Institut de medecine esthetique

Montreal, Quebec, Canada

Site Status

Dr. Nikolis

Mount Royal, Quebec, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 30681793 (View on PubMed)

Other Identifiers

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CONTOUR

Identifier Type: -

Identifier Source: org_study_id

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