An Evaluation of an Injectable Material for Correction of Wrinkles

Phase 3

Withdrawn

• Conditions: Jowls
• Interventions: Device: Calcium Hydroxylapatite injection

• Registration Number: NCT00510081
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-31
• Study First Submitted QC: 2007-07-31
• Study First Posted: 2007-08-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Calcium Hydroxylapatite injection	subjects will receive filler injections

Primary Outcome Measures

Name	Time	Method
Correction of wrinkles	1 week

Secondary Outcome Measures

Name	Time	Method
Development of adverse events	1 week