An Evaluation of an Injectable Material for Correction of Wrinkles - Tabular View

Tracking Information

First Received Date ^ICMJE

July 31, 2007

Last Updated Date

November 23, 2009

Start Date ^ICMJE

July 2007

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Correction of Wrinkles [ Time Frame: 9 Months ]

Change History

Complete list of historical versions of study NCT00510081 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Development of adverse events [ Time Frame: 3.5 months ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

An Evaluation of an Injectable Material for Correction of Wrinkles

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Jowls

Intervention ^ICMJE

Device: Calcium Hydroxylapatite injection

Study Arms / Comparison Groups

Experimental: subjects will receive filler injections

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00510081

Responsible Party

Murad Alam, MD, Northwestern University

Study ID Numbers ^ICMJE

1253-013

Study Sponsor ^ICMJE

Northwestern University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Murad Alam, MD

Northwestern University, Feinberg School of Medicine, Department of Dermatology

Information Provided By

Northwestern University

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP