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An Evaluation of an Injectable Material for Correction of Wrinkles

This study has been withdrawn prior to enrollment.
(The study was not executed. No subjects were enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00510081
First Posted: August 1, 2007
Last Update Posted: December 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Northwestern University
  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 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Correction of wrinkles [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Development of adverse events [ Time Frame: 1 week ]

Enrollment: 0
Study Start Date: July 2007
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
subjects will receive filler injections
Device: Calcium Hydroxylapatite injection
filler injection
Other Name: Radiesse

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510081


Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University, Feinberg School of Medicine, Department of Dermatology
  More Information

Responsible Party: Murad Alam, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00510081     History of Changes
Other Study ID Numbers: 1253-013
First Submitted: July 31, 2007
First Posted: August 1, 2007
Last Update Posted: December 9, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs