An Evaluation of an Injectable Material for Correction of Wrinkles

December 5, 2014 updated by: Northwestern University

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
subjects will receive filler injections
Device: Calcium Hydroxylapatite injection
filler injection
Other Names:
  • Radiesse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correction of wrinkles
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Development of adverse events
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Murad Alam, MD, Northwestern University, Feinberg School of Medicine, Department of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Study Registration Dates

First Submitted

July 31, 2007

First Submitted That Met QC Criteria

July 31, 2007

First Posted (ESTIMATE)

August 1, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1253-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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