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This study has been withdrawn prior to enrollment.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:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00510081
First received: July 31, 2007
Last updated: April 21, 2011
Last verified: April 2011
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: Murad Alam, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00510081     History of Changes
Other Study ID Numbers: 1253-013
Study First Received: July 31, 2007
Last Updated: April 21, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 23, 2014