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Submental FullnessCONTOURNCT02438813

Condition of Submental Fullness and Treatment Outcomes Registry

An observational study of Submental Fullness, run by Kythera Biopharmaceuticals at 95 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Submental Fullness
What is being tested?
Deoxycholic acid, Surgical Procedures and Laser Liposuction
How many people
1,029 participants
Where
95 sitesin 2 countries
Study dates
11 May 2015to 10 Nov 2016
How long will I take part?
12 Weeks
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

95 sites in 2 countries.

95 sites in 2 countries

United States84 sites

  • Main Line Center for Laser Surgery

    Ardmore, Pennsylvania, 19003

  • Carmen Kavali

    Atlanta, Georgia, 30328

  • John Connors Plastic Surgery

    Atlanta, Georgia, 30328

  • Westlake Dermatology And Cosmetic Surgery

    Austin, Texas, 78746

  • Plaza Surgical Center

    Bala-Cynwyd, Pennsylvania, 19004

  • Facial Plastic Surgical Center

    Baltimore, Maryland, 21208

  • Bellaire Dermatology Associates (BDA)

    Bellaire, Texas, 77401-3505

  • Naficy Plastic Surgery And Rejuvenation Center

    Bellevue, Washington, 98004

  • John Joseph, MD

    Beverly Hills, California, 90210

  • The Roxbury Institute

    Beverly Hills, California, 90210

  • Brian M Kinney, MD Inc

    Beverly Hills, California, 90212

  • Boyd

    Birmingham, Michigan, 48009

  • Sanctuary Medical Aesthetic Center

    Boca Raton, Florida, 33431

  • Steven Fagien, MD, PA

    Boca Raton, Florida, 33431

  • Skin Care Research, Inc

    Boca Raton, Florida, 33486

  • Susan H Weinkle Md

    Bradenton, Florida, 34209

  • Bella Skin Institute

    Calabasas, California, 91302

  • Ranella Hirsch

    Cambridge, Massachusetts, 02138

  • Laser & Skin Surgery Center of Indiana

    Carmel, Indiana, 46032

  • Finn Facial Plastics

    Chapel Hill, North Carolina, 27517

  • Dermatology, Laser & Vein Specialists of the Carolinas

    Charlotte, North Carolina, 28207

  • Skin Care Physicians

    Chestnut Hill, Massachusetts, 02467

  • Dermatologic Surgery Center of Washington LLC

    Chevy Chase, Maryland, 20815

  • DeNova Research

    Chicago, Illinois, 60611

  • Skin Research Institute

    Coral Gables, Florida, 33146-1871

  • Jerome R Potozkin MD

    Danville, California, 94526

  • Dermatologic SurgiCenter

    Drexel Hill, Pennsylvania, 19026

  • United Skin Specialists LTD

    Edina, Minnesota, 55424

  • Hema A Sundaram MDPA

    Fairfax, Virginia, 22031

  • Forest Hills Dermatology Group

    Forest Hills, New York, 11375

  • Kathleen L Behr

    Fresno, California, 93720

  • Callender Center for Clinical Research, LLC

    Glenn Dale, Maryland, 20769

  • AboutSkin Dermatology and Dermsurg

    Greenwood Village, Colorado, 80111

  • Practice Dr Angela Beckford

    Hackensack, New Jersey, 07601

  • Maryland Laser Skin & Vein Inst

    Hunt Valley, Maryland, 21030

  • Ocdermatology Lorrie Klein

    Laguna Niguel, California, 92677

  • Westside Aesthetics

    Los Angeles, California, 90025

  • Skin Care and Laser Physicians of Beverly Hills

    Los Angeles, California, 90069

  • Coleman Center For Cosmetic Dermatologic Surgery

    Metairie, Louisiana, 70006

  • The Miami Institute

    Miami, Florida, 33131

  • Miami Dermatology and Laser Institute

    Miami, Florida, 33173

  • Image Dermatology P.C.

    Montclair, New Jersey, 07042-3439

  • New Jersey Plastic Surgery

    Montclair, New Jersey, 07042

  • The Center For Dermatology Cosmetic And Laser Surgery

    Mount Kisco, New York, 10549

  • Brian S. Biesman, M.D.

    Nashville, Tennessee, 37203

  • Lupo Center for Aesthetic and General Dermatology

    New Orleans, Louisiana, 70124

  • Beth Israel Medical Center

    New York, New York, 10003

  • Doris Day Pc

    New York, New York, 10021

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

    New York, New York, 10021

  • JUVA Skin and Laser Center

    New York, New York, 10022-3350

  • Marmur Medical

    New York, New York, 10028

  • New York Laser and Skin Care

    New York, New York, 10028

  • Luxurgery NYC

    New York, New York, 10065

  • Sadick Research Group

    New York, New York, 10075

  • Batniji Facial Plastic Surgery

    Newport Beach, California, 92663

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

    Newport Beach, California, 92663

  • Skin Specialists, P.C.

    Omaha, Nebraska, 68144

  • Teleos Plastic Surgery &. Radiance Medical Group Inc

    Pasadena, California, 91105

  • Research Across America

    Plano, Texas, 75093

  • Oregon Health And Science University Hospital

    Portland, Oregon, 97239

  • Lawrence Green MD LLC

    Rockville, Maryland, 20850

  • Laser And Skin Surgery Center Of Northern California

    Sacramento, California, 95816

  • Gateway Aesthetic Institute & Laser Center

    Salt Lake City, Utah, 84101

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229

  • Dermatology Cosmetic Laser Medical Associates of La JollaInc

    San Diego, California, 92121

  • FacesPlus

    San Diego, California, 92121

  • Goldman Butterwick Fitzpatrick Groff And Fabi Cosmetic Laser

    San Diego, California, 92121

  • The Maas Clinic - San Francisco

    San Francisco, California, 94115-1809

  • Bay Area Cosmetic Dermatology Kathleen M Welsh Md

    San Francisco, California, 94115

  • Vic A Narurkar MD APC

    San Francisco, California, 94115

  • Grossman Dermatology

    Santa Monica, California, 90404

  • Center For Sight

    Sarasota, Florida, 34239

  • Marina I Peredo M.D., P.C.

    Smithtown, New York, 11787

  • Art Of Skin MD

    Solana Beach, California, 92075

  • Premier Clinical Research

    Spokane, Washington, 99202

  • Saint Louis University

    St Louis, Missouri, 63122

  • Skin Spectrum LLC

    Tucson, Arizona, 85704

  • Moradi Md

    Vista, California, 92083

  • Wa Institute Dermatologic Laser Surg

    Washington D.C., District of Columbia, 20005

  • Dermatology Partners

    Wellesley, Massachusetts, 02481

  • Mariwalla Dermatology

    West Islip, New York, 11795

  • Research Institute of the Southeast

    West Palm Beach, Florida, 33401

  • Wilmington Dermatology Center

    Wilmington, North Carolina, 28405

  • Practice Dr Mary Lynn Moran

    Woodside, California, 94062

Other trials in United States

Canada11 sites

  • Medime Institut de medecine esthetique

    Montreal, Quebec, H3S2W1

  • Dr. Nikolis

    Mount Royal, Quebec, H3R 3A1

  • North York General Hospital

    Toronto, Ontario, M2K 1E1

  • Toronto Research Centre

    Toronto, Ontario, M3H 5Y8

  • Compass Dermatology

    Toronto, Ontario, M4S 2N5

  • Sweat Clinics of Canada

    Toronto, Ontario, M5R3N8

  • Dr. Shannon Humphrey, Inc.

    Vancouver, British Columbia, V5Z 4E1

  • Pacific Dermaesthetics

    Vancouver, British Columbia, V6E 4M3

  • Project Skin Vancouver

    Vancouver, British Columbia, V6H 1K9

  • Dr. Jean Carruthers Cosmetic Surgey Inc.

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

  • Bertucci MedSpa, Inc.

    Woodbridge, Ontario, L4L 8E2

Other trials in Canada

About this study

Official title: 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.

Being tested
Deoxycholic acid, Surgical Procedures, Laser Liposuction, Energy Devices, Other Treatments

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deoxycholic acidDrug

    Also called ATX-101, KYBELLA

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

  • Surgical ProceduresProcedure or surgery

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

  • Laser LiposuctionProcedure or surgery

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

  • Energy DevicesDevice

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

  • Other TreatmentsOther

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

Study groups in NCT02438813
Study groupRoleWhat they receive
All Enrolled ParticipantsAll 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.
Receives: Drug: Deoxycholic acid; Procedure: Surgical Procedures; Procedure: Laser Liposuction; Device: Energy Devices; Other: Other Treatments

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 19 Months

Secondary outcomes (6)

  1. 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.

    Measured: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment (EOT) Visit (Up to 18 Months)

  2. 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.

    Measured: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)

  3. 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.

    Measured: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)

  4. 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.

    Measured: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)

  5. 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.

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

  6. 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.

    Measured: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2015 (estimated)
  2. Study start11 May 2015
  3. Primary completion10 Nov 2016
  4. Study completion10 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,029 participants (actual)
Target duration
12 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT02438813
Sponsor's protocol ID
CONTOUR
Acronym
CONTOUR
Status last verified
Oct 2018
First submitted
6 May 2015
Last updated
5 Oct 2018
Data monitoring committee
No

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.

    PubMed 30681793

Questions about this trial

What is this clinical trial studying?

An observational study of Submental Fullness, run by Kythera Biopharmaceuticals at 95 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (time frame: Up to 19 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02438813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.

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