An Evaluation of an Injectable Material for Correction of Wrinkles

Northwestern University

Status and phase

Withdrawn

Phase 3

Conditions

Jowls

Treatments

Device: Calcium Hydroxylapatite injection

Study type

Interventional

Funder types

Other

Identifiers

NCT00510081

1253-013

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.