NCT00414544

Brief Summary

This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

June 10, 2011

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

11 months

First QC Date

December 20, 2006

Results QC Date

March 4, 2011

Last Update Submit

June 22, 2011

Conditions

Facial Wrinkles

Keywords

Nasolabial foldsDermal fillerInjectable dermal fillerSoft tissue augmentation

Outcome Measures

Primary Outcomes (2)

  • Change in Wrinkle Severity Rating Scale

    To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.

    baseline and 6 months

  • Adverse Event Reporting

    6 months

Secondary Outcomes (1)

  • Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months

    3, 9 and 12 months

Study Arms (2)

CosmetaLife

EXPERIMENTAL

Test Article was given at start and two week follow up if necessary, up to a maximum dose of 2 cc to achieve optimal correction as determined by investigator.

Device: CosmetaLife

Restylane

ACTIVE COMPARATOR

Control Article was given at start and two week follow up if necessary, up to a maximum dose of 2 cc to achieve optimal correction as determined by investigator.

Device: Restylane

Interventions

CosmetaLifeDEVICE

Dermal filler

CosmetaLife
RestylaneDEVICE

Dermal filler

Restylane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age or older
  • Patients with moderate nasolabial folds (3-4 WSRS scale)
  • Patients willing to provide written informed consent for their participation in the study
  • Patients willing to abstain from other facial cosmetic procedures through the 12 month follow-up visit

You may not qualify if:

  • Patients with any aesthetic facial therapy within 6 months prior to
  • Patients with an any reaction to the skin test
  • Patients with a history of autoimmune disorder, lidocaine reactions, allergy to heparin, other severe or chronic allergies
  • Patients with a current disease state that can effect the immunoresponse, or patients on immunosuppressive therapy
  • Patients with an active infection of any kind, skin disease, connective tissue disorder
  • Patients who are pregnant or lactating
  • Patients enrolled in another investigational clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beauty Renewed

Tracy, California, 95376, United States

Location

North Atlantic Plastic and Reconstructive Surgery

Roswell, Georgia, 30076, United States

Location

SkinCare Physicians of Chestnut Hill

Chestnut Hill, Massachusetts, 02467, United States

Location

Cosmetic Care Center, LLC

Edina, Minnesota, 55424, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Results Point of Contact

Title
Dr. David B. Masters
Organization
Cosmeta, A Gel-Del Technolgies Company
dmasters@gel-del.com
651 209-0707

Study Officials

  • David B. Masters, Ph.D.

    Cosmeta™ Corp

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 21, 2006

Study Start

October 1, 2006

Primary Completion

September 1, 2007

Study Completion

March 1, 2008

Last Updated

June 27, 2011

Results First Posted

June 10, 2011

Record last verified: 2011-06

Locations

US(5)