Condition of Submental Fullness and Treatment Outcomes Registry

NCT02438813 | Completed Results

• 1 other identifier: CONTOUR
• Study Type: observational
• Target: 1,029
• Locations: 2 countries
• Sites: 95

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.

Conditions

Submental Fullness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

  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)

  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)

  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)

  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)

  Baseline (Day 1) to End of Treatment Visit (Up to 18 Months)

Study Arms (1)

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; Procedure: Surgical Procedures; Procedure: Laser Liposuction; Device: Energy Devices; Other: Other Treatments

Interventions

Deoxycholic acid DRUG

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

Also known as: ATX-101, KYBELLA

All Enrolled Participants

Surgical Procedures PROCEDURE

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

All Enrolled Participants

Laser Liposuction PROCEDURE

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

All Enrolled Participants

Energy Devices DEVICE

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

All Enrolled Participants

Other Treatments OTHER

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

All Enrolled Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kythera Biopharmaceuticals: lead

Study Sites (95)

Skin Spectrum LLC

Tucson, Arizona, 85704, United States

Location

John Joseph, MD

Beverly Hills, California, 90210, United States

Location

The Roxbury Institute

Beverly Hills, California, 90210, United States

Location

Brian M Kinney, MD Inc

Beverly Hills, California, 90212, United States

Location

Bella Skin Institute

Calabasas, California, 91302, United States

Location

Jerome R Potozkin MD

Danville, California, 94526, United States

Location

Kathleen L Behr

Fresno, California, 93720, United States

Location

Ocdermatology Lorrie Klein

Laguna Niguel, California, 92677, United States

Location

Westside Aesthetics

Los Angeles, California, 90025, United States

Location

Skin Care and Laser Physicians of Beverly Hills

Los Angeles, California, 90069, United States

Location

Batniji Facial Plastic Surgery

Newport Beach, California, 92663, United States

Location

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

Newport Beach, California, 92663, United States

Location

Teleos Plastic Surgery &. Radiance Medical Group Inc

Pasadena, California, 91105, United States

Location

Laser And Skin Surgery Center Of Northern California

Sacramento, California, 95816, United States

Location

Dermatology Cosmetic Laser Medical Associates of La JollaInc

San Diego, California, 92121, United States

Location

FacesPlus

San Diego, California, 92121, United States

Location

Goldman Butterwick Fitzpatrick Groff And Fabi Cosmetic Laser

San Diego, California, 92121, United States

Location

The Maas Clinic - San Francisco

San Francisco, California, 94115-1809, United States

Location

Bay Area Cosmetic Dermatology Kathleen M Welsh Md

San Francisco, California, 94115, United States

Location

Vic A Narurkar MD APC

San Francisco, California, 94115, United States

Location

Grossman Dermatology

Santa Monica, California, 90404, United States

Location

Art Of Skin MD

Solana Beach, California, 92075, United States

Location

Moradi Md

Vista, California, 92083, United States

Location

Practice Dr Mary Lynn Moran

Woodside, California, 94062, United States

Location

AboutSkin Dermatology and Dermsurg

Greenwood Village, Colorado, 80111, United States

Location

Wa Institute Dermatologic Laser Surg

Washington D.C., District of Columbia, 20005, United States

Location

Sanctuary Medical Aesthetic Center

Boca Raton, Florida, 33431, United States

Location

Steven Fagien, MD, PA

Boca Raton, Florida, 33431, United States

Location

Skin Care Research, Inc

Boca Raton, Florida, 33486, United States

Location

Susan H Weinkle Md

Bradenton, Florida, 34209, United States

Location

Skin Research Institute

Coral Gables, Florida, 33146-1871, United States

Location

The Miami Institute

Miami, Florida, 33131, United States

Location

Miami Dermatology and Laser Institute

Miami, Florida, 33173, United States

Location

Center For Sight

Sarasota, Florida, 34239, United States

Location

Research Institute of the Southeast

West Palm Beach, Florida, 33401, United States

Location

Carmen Kavali

Atlanta, Georgia, 30328, United States

Location

John Connors Plastic Surgery

Atlanta, Georgia, 30328, United States

Location

DeNova Research

Chicago, Illinois, 60611, United States

Location

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

Coleman Center For Cosmetic Dermatologic Surgery

Metairie, Louisiana, 70006, United States

Location

Lupo Center for Aesthetic and General Dermatology

New Orleans, Louisiana, 70124, United States

Location

Facial Plastic Surgical Center

Baltimore, Maryland, 21208, United States

Location

Dermatologic Surgery Center of Washington LLC

Chevy Chase, Maryland, 20815, United States

Location

Callender Center for Clinical Research, LLC

Glenn Dale, Maryland, 20769, United States

Location

Maryland Laser Skin & Vein Inst

Hunt Valley, Maryland, 21030, United States

Location

Lawrence Green MD LLC

Rockville, Maryland, 20850, United States

Location

Ranella Hirsch

Cambridge, Massachusetts, 02138, United States

Location

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Dermatology Partners

Wellesley, Massachusetts, 02481, United States

Location

Boyd

Birmingham, Michigan, 48009, United States

Location

United Skin Specialists LTD

Edina, Minnesota, 55424, United States

Location

Saint Louis University

St Louis, Missouri, 63122, United States

Location

Skin Specialists, P.C.

Omaha, Nebraska, 68144, United States

Location

Practice Dr Angela Beckford

Hackensack, New Jersey, 07601, United States

Location

Image Dermatology P.C.

Montclair, New Jersey, 07042-3439, United States

Location

New Jersey Plastic Surgery

Montclair, New Jersey, 07042, United States

Location

Forest Hills Dermatology Group

Forest Hills, New York, 11375, United States

Location

The Center For Dermatology Cosmetic And Laser Surgery

Mount Kisco, New York, 10549, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Doris Day Pc

New York, New York, 10021, United States

Location

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

New York, New York, 10021, United States

Location

JUVA Skin and Laser Center

New York, New York, 10022-3350, United States

Location

Marmur Medical

New York, New York, 10028, United States

Location

New York Laser and Skin Care

New York, New York, 10028, United States

Location

Luxurgery NYC

New York, New York, 10065, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

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

Smithtown, New York, 11787, United States

Location

Mariwalla Dermatology

West Islip, New York, 11795, United States

Location

Finn Facial Plastics

Chapel Hill, North Carolina, 27517, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

Oregon Health And Science University Hospital

Portland, Oregon, 97239, United States

Location

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

Plaza Surgical Center

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Dermatologic SurgiCenter

Drexel Hill, Pennsylvania, 19026, United States

Location

Brian S. Biesman, M.D.

Nashville, Tennessee, 37203, United States

Location

Westlake Dermatology And Cosmetic Surgery

Austin, Texas, 78746, United States

Location

Bellaire Dermatology Associates (BDA)

Bellaire, Texas, 77401-3505, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Gateway Aesthetic Institute & Laser Center

Salt Lake City, Utah, 84101, United States

Location

Hema A Sundaram MDPA

Fairfax, Virginia, 22031, United States

Location

Naficy Plastic Surgery And Rejuvenation Center

Bellevue, Washington, 98004, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Dr. Shannon Humphrey, Inc.

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Pacific Dermaesthetics

Vancouver, British Columbia, V6E 4M3, Canada

Location

Project Skin Vancouver

Vancouver, British Columbia, V6H 1K9, Canada

Location

Dr. Jean Carruthers Cosmetic Surgey Inc.

Vancouver, B. C., British Columbia, V5Z 4E1, Canada

Location

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

Compass Dermatology

Toronto, Ontario, M4S 2N5, Canada

Location

Sweat Clinics of Canada

Toronto, Ontario, M5R3N8, Canada

Location

Bertucci MedSpa, Inc.

Woodbridge, Ontario, L4L 8E2, Canada

Location

Medime Institut de medecine esthetique

Montreal, Quebec, H3S2W1, Canada

Location

Dr. Nikolis

Mount Royal, Quebec, H3R 3A1, Canada

Location

Related Publications (1)

• 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.

  PMID: 30681793 DERIVED

MeSH Terms

Interventions

Deoxycholic Acid; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Results Point of Contact

• Title: Medical Director/ Epidemiologist
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Rina Patel, MS, CCRA

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: May 11, 2015
• Primary Completion: November 10, 2016
• Study Completion: November 10, 2016
• Last Updated: October 5, 2018
• Results First Posted: October 5, 2018

Record last verified: 2018-10

Locations

CA (11); US (84)