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Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR)

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ClinicalTrials.gov Identifier: NCT02438813
Recruitment Status : Completed
First Posted : May 8, 2015
Results First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals

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.

Condition or disease Intervention/treatment
Submental Fullness Drug: Deoxycholic acid Procedure: Surgical Procedures Procedure: Laser Liposuction Device: Energy Devices Other: Other Treatments

Study Type : Observational [Patient Registry]
Actual Enrollment : 1029 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry (A Registry of Submental Fullness, Treatment Options Administered, and Associated Outcomes)
Actual Study Start Date : May 11, 2015
Actual Primary Completion Date : November 10, 2016
Actual Study Completion Date : November 10, 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Up to 19 Months ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) [ Time Frame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment (EOT) Visit (Up to 18 Months) ]
    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.

  2. Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) [ Time Frame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) ]
    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.

  3. Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) [ Time Frame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) ]
    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.

  4. Change From Baseline in the Subject Self Rating Scale (SSRS) [ Time Frame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) ]
    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.

  5. Change From Baseline in the Patient Self-Perception of Age (SPA) [ Time Frame: Baseline (Day 1) to End of Treatment Visit (Up to 18 Months) ]
    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.

  6. Change From Baseline in the Submental Skin Laxity Scale (SMSLG) [ Time Frame: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months) ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438813


  Show 95 Study Locations
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Study Director: Rina Patel, MS, CCRA Allergan

Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT02438813     History of Changes
Other Study ID Numbers: CONTOUR
First Posted: May 8, 2015    Key Record Dates
Results First Posted: October 5, 2018
Last Update Posted: October 5, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents