An Open Label Evaluation of the Safety and Efficacy of Calcium Hydroxylapatite (Radiesse®) Injection in the Correction of Jowl-Associated Chin Notches

Northwestern University0 sitesJuly 2007

ConditionsJowls

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Jowls
Sponsor: Northwestern University
Primary Endpoint: Correction of wrinkles
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The objective of this study is to determine the effectiveness of a filler in improving wrinkles.

Detailed Description

The primary objective of this study is to determine whether focal injection of calcium hydroxylapatite (Radiesse®), an injectable biodegradable filler, into jowl-induced chin notches can result in safe, aesthetically pleasing, and long-lasting correction of these.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

February 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Northwestern University

Eligibility Criteria

Inclusion Criteria

•Age 40-65
•Have wrinkles
•The subjects are in good health.
•The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria

•Subjects who have received within the past 3 months or are planning to receive in the next 6 months, botulinum toxin injections for correction of wrinkles.
•Subjects who have received within the past one year any soft tissue augmentation material into the chin and experimental area (defined as any area on the face below the lower lip vermilion, excluding the lateral lip marionette line up to 1 cm below this level).
•Subjects with prior history of nodule formation or hypersensitivity reactions to lidocaine or medium-term augmentation materials, including hyaluronic acid derivatives, poly-L-lactic acid, and calcium hydroxylapatite.
•Subjects who are currently using anticoagulation therapy.
•Subjects who have a history of bleeding disorders.
•Subjects who are unable to understand the protocol or to give informed consent.
•Subjects with mental illness.