Overview

This trial is active, not recruiting.

Condition submental fullness
Treatment no intervention
Sponsor Kythera Biopharmaceuticals
Start date May 2015
End date November 2016
Trial size 1031 participants
Trial identifier NCT02438813, CONTOUR

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Safety as assessed by adverse events
time frame: 15 months

Secondary Outcomes

Measure
Efficacy assessments using clinician rating scales
time frame: 15 months
Efficacy assessments using patient reported rating scales
time frame: 15 months
Efficacy assessment using submental skin laxity grade scale
time frame: 15 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry (A Registry of Submental Fullness, Treatment Options Administered, and Associated Outcomes)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Kythera Biopharmaceuticals.