An Evaluation of an Injectable Material for Correction of Wrinkles
NCT ID: NCT00510081
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2007-07-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
subjects will receive filler injections
Calcium Hydroxylapatite injection
filler injection
Interventions
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Calcium Hydroxylapatite injection
filler injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
65 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Northwestern University
Principal Investigators
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Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University, Feinberg School of Medicine, Department of Dermatology
Countries
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Other Identifiers
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1253-013
Identifier Type: -
Identifier Source: org_study_id