- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01012388
Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
April 19, 2013 updated by: Merz North America, Inc.
Post-Marketing Study of Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States
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Maryland
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Chevy Chase, Maryland, United States
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Michigan
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Ypsilanti, Michigan, United States
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New York
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New York, New York, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is at least 18 years of age.
- Has Fitzpatrick Skin Type IV, V, or VI.
- Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months.
Exclusion Criteria:
- Has history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
- Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
- Has nasolabial folds that are too severe to be corrected in one treatment session.
- Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold.
- Is pregnant, lactating, or not using acceptable contraception.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiesse
|
Calcium hydroxylapatite particles suspected in an aqueous based gel carrier
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment
Time Frame: 3 months
|
Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely
|
3 months
|
Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment
Time Frame: 6 months
|
Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
November 11, 2009
First Submitted That Met QC Criteria
November 12, 2009
First Posted (Estimate)
November 13, 2009
Study Record Updates
Last Update Posted (Estimate)
April 26, 2013
Last Update Submitted That Met QC Criteria
April 19, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- P1206248
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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