- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01212809
Comparative Study of Reconstituted JUVÉDERM® Ultra vs COSMODERM® 1 for Lip and Cheek Lines, Folds or Wrinkles (JUVE_COSMO_1)
September 9, 2011 updated by: Steven Fagien
A Prospective, Open Label, Randomized, Comparative, Split-Face Study Evaluating Reconstituted JUVÉDERM® Ultra Injectable Gel Versus COSMODERM® 1 Human Based Collagen Implant for the Treatment of Vertical Lip Rhytids and Radial Cheek Lines
This study is being done to evaluate the differences in the performance of two well known injectable dermal fillers commonly used for the cosmetic treatment of age lines above the lips and on the cheeks when compared to each other in the same patient.
The products being tested are Juvéderm® Ultra and CosmoDerm® 1.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single center, prospective, open label, randomized, comparative, split-face study in adult females or males aged 25 to 70 years seeking treatment with reconstituted Juvéderm® Ultra and CosmoDerm® 1 human-based collagen implant for moderate to severe vertical lip rhytids and/or radial cheek lines.
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
Florida
-
Boca Raton, Florida, United States, 33431
- Steven Fagien, MD, PA
-
-
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
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult females or males, aged 25 to 70 years;
- Subjects must be seeking treatment with Juvéderm Ultra and CosmoDerm 1 injections for vertical lip rhytids or radial cheek lines;
- Subjects must have one or more moderate to severe vertical lip rhytids and/or moderate to severe radial cheek lines based on the physician evaluator assessment (0-3 scale);
- Women must either be of non-childbearing potential (i.e., surgically sterilized or post-menopausal) or if of childbearing potential, must not be pregnant (as documented by a negative urine pregnancy test at the baseline examination) or lactating and must be practicing a medically acceptable method of birth control;
- Subjects must be willing and able to provide written informed consent;
- Subjects must be willing and able to follow the procedures outlined in this protocol.
Exclusion Criteria:
- Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control;
- Previous Botox treatment to the lower two-thirds of the face within the past 6 months for subjects who will have injections into their radial cheek lines. Note: this exclusion criterion does not apply to subjects who only will have injections into lip rhytids unless the previous Botox treatment was administered within the past 6 months to the upper lip region;
- Previous semipermanent injectable filler therapy to the mid-lower face within the past year or any prior history of permanent filler therapy injection to the mid-lower face;
- Prior cosmetic procedures (i.e., facelift, etc.) or visible scars that may affect evaluation of response and/or quality of photography in the opinion of the investigator;
- Known allergy or sensitivity to any of the treatment injections or their components, including known or suspected lidocaine hypersensitivity;
- Known severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies;
- Subjects with an infection at an injection site or systemic infection (in this case, postpone study entry until one week following recovery);
- Subjects requiring treatment with major anticoagulants (such as Coumadin) or antiplatelets (such as Plavix) during the study; low-dose aspirin treatment or antiinflammatory medication with potential anticoagulant or antiplatelet effect may be allowed at the investigator's discretion;
- Concurrent participation in an investigational drug or device study or participation within 30 days of study start;
- Subjects are not to undergo any additional cosmetic procedures during the study period;
- Subjects are not to change use of any facial products up to 6 months prior to enrollment and during study period;
- Subjects with a history of poor cooperation, non-compliance with medical treatment, or unreliability.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Juvéderm Ultra
Juvéderm Ultra injection
|
Split-face injection of Juvéderm Ultra into vertical lip rhytids and radial cheek lines on one side of face
Other Names:
|
Active Comparator: Cosmoderm 1
Cosmoderm 1 injection
|
Split-face injection of Cosmoderm 1 into vertical lip rhytids and radial cheek lines on one side of face
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Assessment of Improvement by Physician Evaluator
Time Frame: 3 days, 2 and 6 weeks, 4 and 6 months
|
Global Assessment of Improvement by Physician Evaluator, including Facial Photographs, Vertical Lip Rhytids and Radial Cheek Line Rating Scales
|
3 days, 2 and 6 weeks, 4 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Efficacy, Pain, Adverse Event Assessments
Time Frame: 3 days, 2 and 6 weeks, 4 and 6 months
|
|
3 days, 2 and 6 weeks, 4 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven Fagien, MD, Steven Fagien, MD, PA
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
September 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
September 29, 2010
First Submitted That Met QC Criteria
September 30, 2010
First Posted (Estimate)
October 1, 2010
Study Record Updates
Last Update Posted (Estimate)
September 12, 2011
Last Update Submitted That Met QC Criteria
September 9, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JUVE_COSMO_1-10-01
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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