Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02438813
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : January 23, 2017
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 Other: No Intervention

Study Type : Observational [Patient Registry]
Actual Enrollment : 1031 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)
Study Start Date : May 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Primary Outcome Measures :
  1. Safety as assessed by adverse events [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. Efficacy assessments using clinician rating scales [ Time Frame: 15 months ]
  2. Efficacy assessments using patient reported rating scales [ Time Frame: 15 months ]
  3. Efficacy assessment using submental skin laxity grade scale [ Time Frame: 15 months ]

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.

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 identifier (NCT number): NCT02438813

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Sponsors and Collaborators
Kythera Biopharmaceuticals
Study Director: Rina Patel, MS, CCRA Allergan

Responsible Party: Kythera Biopharmaceuticals Identifier: NCT02438813     History of Changes
Other Study ID Numbers: CONTOUR
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017