Facial WrinklesPhase 2NCT00414544
Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds
A Phase 2 study testing CosmetaLife and Restylane in people with Facial Wrinkles, run by Cosmeta at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- CosmetaLife and Restylane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2006to Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
SkinCare Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, 02467
Cosmetic Care Center, LLC
Edina, Minnesota, 55424
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
North Atlantic Plastic and Reconstructive Surgery
Roswell, Georgia, 30076
Beauty Renewed
Tracy, California, 95376
About this study
Official title: A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds
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).
Read the detailed description
Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.
- Conditions
- Facial Wrinkles
- Being tested
- CosmetaLife, Restylane
- Keywords
- Nasolabial folds, Dermal filler, Injectable dermal filler, Soft tissue augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CosmetaLifeDevice
Dermal filler
RestylaneDevice
Dermal filler
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Restylane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months
Adverse Event Reporting
Measured: 6 months
Secondary outcomes (1)
Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months
Measured: 3, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Facial WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmeta
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cosmeta Corp, A Gel-Del Technologies Company
- Investigators
- David B. Masters, Ph.D., Study director, Cosmeta™ Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414544
- Sponsor's protocol ID
- CosmetaLife 1
- Status last verified
- Jun 2011
- First submitted
- 20 Dec 2006
- Last updated
- 27 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT00414544
- Acronym / sponsor ID
- CosmetaLife 1
- Conditions
- Facial Wrinkles
- Keywords
- Nasolabial folds, Dermal filler, Injectable dermal filler, Soft tissue augmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- CosmetaIndustry (pharma, biotech, devices)
- Collaborators
- Cosmeta Corp, A Gel-Del Technologies Company
- Study start
- Oct 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 21 Dec 2006 (estimated)
- Results
- Posted 10 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CosmetaLife | Experimental | Device: CosmetaLifeTest 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. |
| Restylane | Active comparator | Device: RestylaneControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CosmetaLifeDermal filler | Device | CosmetaLife |
| RestylaneDermal filler | Device | Restylane |
Primary outcome
Change in Wrinkle Severity Rating Scale
Time frame: baseline and 6 months
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.
Adverse Event Reporting
Time frame: 6 months
1 secondary outcome
Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months
Time frame: 3, 9 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B. Masters, Ph.D. study director
Cosmeta™ Corp
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CosmetaLife and Restylane in people with Facial Wrinkles, run by Cosmeta at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wrinkle Severity Rating Scale (time frame: baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.