Comparative Study of Reconstituted JUVÉDERM® Ultra vs COSMODERM® 1 for Lip and Cheek Lines, Folds or Wrinkles

NCT01212809 | Completed Phase 4

• 1 other identifier: JUVE_COSMO_1-10-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrinsic Aging of Skin

Outcome Measures

Primary Outcomes (1)

• Global Assessment of Improvement by Physician Evaluator

  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 Outcomes (1)

• Patient Efficacy, Pain, Adverse Event Assessments

  3 days, 2 and 6 weeks, 4 and 6 months

Study Arms (2)

Juvéderm Ultra

ACTIVE COMPARATOR

Juvéderm Ultra injection

Device: Juvéderm Ultra

Cosmoderm 1

ACTIVE COMPARATOR

Cosmoderm 1 injection

Device: Cosmoderm 1

Interventions

Juvéderm Ultra DEVICE

Split-face injection of Juvéderm Ultra into vertical lip rhytids and radial cheek lines on one side of face

Also known as: Juvéderm Ultra injectable gel (crosslinked hyaluronic acid)

Juvéderm Ultra

Cosmoderm 1 DEVICE

Split-face injection of Cosmoderm 1 into vertical lip rhytids and radial cheek lines on one side of face

Also known as: Cosmoderm 1 human-based collagen implant

Cosmoderm 1

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Steven Fagien: lead

Study Sites (1)

Steven Fagien, MD, PA

Boca Raton, Florida, 33431, United States

Location

Study Officials

• Steven Fagien, MD

  Steven Fagien, MD, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 1, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

US (1)