An Evaluation of an Injectable Material for Correction of Wrinkles

This study has been terminated.

( No longer relevant for investigation )

First Received: July 31, 2007 Last Updated: November 23, 2009 History of Changes

Sponsor:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00510081

Purpose

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

Condition	Intervention	Phase
Jowls	Device: Calcium Hydroxylapatite injection	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Evaluation of the Safety and Efficacy of Calcium Hydroxylapatite (Radiesse®) Injection in the Correction of Jowl-Associated Chin Notches

Resource links provided by NLM:

MedlinePlus related topics: Calcium

Drug Information available for: Calcium gluconate Durapatite

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Correction of wrinkles [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Development of adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	July 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental subjects will receive filler injections	Device: Calcium Hydroxylapatite injection filler injection

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.

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510081

Locations

United States, Illinois
Northwestern University, Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Murad Alam, MD

Northwestern University, Feinberg School of Medicine, Department of Dermatology

More Information

No publications provided

Responsible Party:	Northwestern University ( Murad Alam, MD )
Study ID Numbers:	1253-013
Study First Received:	July 31, 2007
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00510081 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 27, 2009