NCT01212809

CompletedPhase 4

Comparative Study of Reconstituted JUVÉDERM® Ultra vs COSMOD...

Steven Fagien Source

Steven Fagien

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

JUVE_COSMO_1-10-01

Study Type

interventional

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

September 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2011

Actual (reported)

Study Completion

June 2011

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: June 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 29, 2010
Actual (reported)
First Posted
October 1, 2010
Actual (reported)
Primary Completion
April 2011
Actual (reported)
Study Completion
June 2011
Actual (reported)

Last Updated: September 12, 2011
Status Verified: September 2011
Last Update Submitted: September 9, 2011

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 UltraDevice

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 1Device

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

Eligibility Criteria

Age25 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Steven Fagien
Otherlead

Study Sites (1)

Steven Fagien, MD, PA

Boca Raton, Florida, 33431, United States

Study Officials

Steven Fagien, MD
Steven Fagien, MD, PA
PRINCIPAL INVESTIGATOR

Enrollment

30 participants (actual enrollment reported by the registry).

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 2010

Date type not reported

This date has not been verified as actual or estimated.

Also known as: Cosmoderm 1 human-based collagen implant

Cosmoderm 1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Contact the study team to confirm eligibility.

Primary Completion

April 2011

Actual (reported)

Study Completion

June 2011

Actual (reported)

Last Updated

September 12, 2011

Record last verified: 2011-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01212809
Data provider: ClinicalTrials.gov
Source updated: 2011-09-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:30 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Juvéderm Ultra

Cosmoderm 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations