NCT00510081

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2007

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

1.6 years

First QC Date

July 31, 2007

Last Update Submit

December 5, 2014

Conditions

Jowls

Outcome Measures

Primary Outcomes (1)

  • Correction of wrinkles

    1 week

Secondary Outcomes (1)

  • Development of adverse events

    1 week

Study Arms (1)

1

EXPERIMENTAL

subjects will receive filler injections

Device: Calcium Hydroxylapatite injection

Interventions

Calcium Hydroxylapatite injectionDEVICE

filler injection

Also known as: Radiesse
1

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Murad Alam, MD

    Northwestern University, Feinberg School of Medicine, Department of Dermatology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2007

First Posted

August 1, 2007

Study Start

July 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

December 9, 2014

Record last verified: 2014-12