Facial WrinklesPhase 3NCT00877279
Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft
A Phase 3 study testing CosmoDerm1 and Belotero Soft in people with Facial Wrinkles, run by Merz North America, Inc. at 5 sites in United States.
Trial summary
This study is to determine the safety and effectiveness of Belotero® Soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- CosmoDerm1 and Belotero Soft
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2007to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have bilateral facial wrinkles, such as nasolabial folds
Who cannot join
- Other nasolabial fold correction within 6 months prior to study entry.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Skin Care & Laser Physicians of Beverly Hills
Los Angeles, California, 90069
William Coleman, III, MD
Metairie, Louisiana, 70006
Savin Dermatology Center
New Haven, Connecticut, 06511
Maas Clinic
San Francisco, California, 94115
Dermatology Surgery and Laser Center
White Plains, New York, 10604
About this study
Official title: A Randomized,Blinded,Controlled,Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero® Soft, After Superficial to Mid Dermal Implantation for Correction of Mild Facial Wrinkles Over 4 Weeks.
This study is to determine the safety and effectiveness of Belotero® Soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds.
Read the detailed description
The purpose of the study is to see if Belotero® Soft is safe and effective for correction of mild facial wrinkles, such as nasolabial folds. The second objective of the study is to see if Belotero® Soft works better than the active comparator. Subjects will receive Belotero® Soft injection to one side of the face and the active comparator to the other side of the face.
- Conditions
- Facial Wrinkles
- Being tested
- CosmoDerm1, Belotero Soft
- Keywords
- Facial wrinkles, Nasolabial folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CosmoDerm1Device
CosmoDerm1 is a single use syringe, injected into the mid dermal layer.
Belotero SoftDevice
Dermal Filler
| Study group | Role | What they receive |
|---|---|---|
| Belotero® Soft | Experimental | Comparator will be given into the opposite side of the face that Belotero® Soft was administered for facial wrinkles, such as nasolabial folds. Receives: Device: Belotero Soft |
| CosmoDerm1 | Active comparator | Not described Receives: Device: CosmoDerm1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of the facial wrinkle
Measured: 2 weeks and 4 weeks
Secondary outcomes (1)
Investigator and subject assessments
Measured: 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startNov 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rhoda Narins, MD, Principal investigator, Dermatology Surgery and Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877279
- Sponsor's protocol ID
- MUS 90028-0717/1
- Status last verified
- Oct 2013
- First submitted
- 3 Apr 2009
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Blinded,Controlled,Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero® Soft, After Superficial to Mid Dermal Implantation for Correction of Mild Facial Wrinkles Over 4 Weeks.
- ClinicalTrials.gov ID
- NCT00877279
- Acronym / sponsor ID
- MUS 90028-0717/1
- Conditions
- Facial Wrinkles
- Keywords
- Facial wrinkles, Nasolabial folds
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to determine the safety and effectiveness of Belotero® Soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds.
Detailed description
The purpose of the study is to see if Belotero® Soft is safe and effective for correction of mild facial wrinkles, such as nasolabial folds. The second objective of the study is to see if Belotero® Soft works better than the active comparator. Subjects will receive Belotero® Soft injection to one side of the face and the active comparator to the other side of the face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belotero® Soft | Experimental | Device: Belotero SoftComparator will be given into the opposite side of the face that Belotero® Soft was administered for facial wrinkles, such as nasolabial folds. |
| CosmoDerm1 | Active comparator | Device: CosmoDerm1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must have bilateral facial wrinkles, such as nasolabial folds
Key exclusion criteria (1 listed)
- Other nasolabial fold correction within 6 months prior to study entry.
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 |
|---|---|---|
| CosmoDerm1CosmoDerm1 is a single use syringe, injected into the mid dermal layer. | Device | CosmoDerm1 |
| Belotero SoftDermal Filler | Device | Belotero® Soft |
Primary outcome
The severity of the facial wrinkle
Time frame: 2 weeks and 4 weeks
1 secondary outcome
Investigator and subject assessments
Time frame: 2 weeks and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
Related trials for Facial Wrinkles
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment
Skin Laxity, Wrinkle
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Not yet recruiting
Evaluation of MD60002 Device for Facial Skin Aging
Facial Wrinkles, Skin Aging
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.
Rhoda Narins, MD principal investigator
Dermatology Surgery and Laser Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CosmoDerm1 and Belotero Soft in people with Facial Wrinkles, run by Merz North America, Inc. 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 1 inclusion and 1 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 15 Nov 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The severity of the facial wrinkle (time frame: 2 weeks and 4 weeks). 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 15 Nov 2013.