Correction of Nasolabial Folds and Lip AugmentationPhase 3NCT00764257
PREVELLE Shape (CX002) Dermal Filler Protocol
A Phase 3 study testing PREVELLE Shape and Restylane in people with Correction of Nasolabial Folds and Lip Augmentation, run by Mentor Worldwide, LLC at 1 site in United States.
Trial summary
The purpose of this study was to assess PREVELLE Shape (CX002), with respect to safety and efficacy for one year following treatment, for correction of facial nasolabial folds and when applied as an intradermal implant for lip augmentation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Correction of Nasolabial Folds and Lip Augmentation
- What is being tested?
- PREVELLE Shape and Restylane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jan 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who gave written informed consent to participate.
- Male or female subjects aged between 30 and 60 years inclusive (nasolabial fold cohort) or male or female subjects 18 years of age and older (lip augmentation cohort).
- Subjects with NLFs that had shallow wrinkles, moderately deep wrinkles, or deep wrinkles with well defined edges (level 2, 3, or 4 on the six-point categorical rating scale), suitable for soft tissue augmentation or subjects who desired lip enlargement.
Who cannot join
- Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
- Subjects with a known hypersensitivity to sodium hyaluronate, lidocaine, xylocaine, or epinephrine.
- Subjects with known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies.
- Subjects with any serious skin disease, e.g., Eczema and psoriasis of the face, severe rosacea, scleroderma, local infections and severe acne.
- Subjects with cancerous or precancerous lesions in either the right or left NLF or the lips.
- Subjects with diabetes, coagulation disorders, connective tissue disorders, lipodystrophy, or other serious systemic disease.
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- Subjects with active herpes labialis.
- Subjects infected with HIV and/or who received immunosuppressive therapy.
- Subjects who received injections of resorbable tissue augmentation materials to the NLFs or the lips within 18 months prior to baseline.
- Subjects who received permanent tissue implant materials to the NLFs or the lips.
- Subjects who received any experimental drug or device within the previous three months.
- Subjects who were to undergo another facial aesthetic procedure (including surgical, dermal implantation, Botox treatment, dermabrasion, facial massage, photo-aging treatments e.g., Retin-A and other related creams), during the entire 12-month study period
- Subjects who were to undergo major facial plastic surgery (e.g. rhinoplasty with or without implant, eyelid lift, facelift, etc).
- Subjects who were known alcohol or drug abusers.
- Female subjects who were pregnant or lactating or were intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.
- Possessed any psychological condition, or was under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s), would constitute an unwarranted risk.
- Worked for Mentor or the study Investigator or were directly-related to anyone that worked for Mentor or the study doctor.
- Subjects requiring facial soft tissue augmentation because of traumatic injury (nasolabial fold cohort only).
- Subjects with none, just perceptible or very deep nasolabial wrinkles (0, 1, or, 5 points on the six-point Lemperle rating scale) (nasolabial fold cohort only).
- Subjects who were treated with Retin-A four weeks prior to the baseline visit (nasolabial fold cohort only).
- Subjects who were treated with Botox anywhere on the face within six months prior to the baseline visit (nasolabial fold cohort only).
- Subjects who received laser resurfacing anywhere on the face within 12 months prior to the baseline visit (nasolabial fold cohort only).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mentor Worldwide, LLC
Santa Barbara, California, 93111
About this study
Official title: A Multicenter, Evaluator-Masked Study to Assess the Efficacy and Safety of Mentor's CX002 Dermal Filler Medical Device, When Applied as an Intradermal Implant for the Correction of Facial Wrinkles and Lip Augmentation (CX002 Dermal Filler Protocol)
The purpose of this study was to assess PREVELLE Shape (CX002), with respect to safety and efficacy for one year following treatment, for correction of facial nasolabial folds and when applied as an intradermal implant for lip augmentation.
- Being tested
- PREVELLE Shape, Restylane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVELLE ShapeDevice
RestylaneDevice
| Study group | Role | What they receive |
|---|---|---|
| PREVELLE Shape | Experimental | Not described Receives: Device: PREVELLE Shape |
| Restylane | Active comparator | Not described Receives: Device: Restylane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the safety and efficacy of CX002 when applied to the NLFs or lips.
The primary aim of the study is to assess CX002, with respect to safety and efficacy during the six months following treatment, in two subject cohorts:
- When applied as an intradermal implant for the correction of facial nasolabial folds (Nasolabial Fold Cohort). Nasolabial folds were chosen as the fold/wrinkle for treatment as they are often the most severe facial wrinkles, representing a "worst-case" scenario
- When applied as an intradermal implant for lip augmentation (Lip Augmentation Cohort)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startOct 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Correction of Nasolabial Folds and Lip AugmentationStudies 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
Sponsor and investigators
- Lead sponsor
- Mentor Worldwide, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764257
- Sponsor's protocol ID
- 111990-0104-3
- Status last verified
- Dec 2011
- First submitted
- 1 Oct 2008
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Evaluator-Masked Study to Assess the Efficacy and Safety of Mentor's CX002 Dermal Filler Medical Device, When Applied as an Intradermal Implant for the Correction of Facial Wrinkles and Lip Augmentation (CX002 Dermal Filler Protocol)
- ClinicalTrials.gov ID
- NCT00764257
- Acronym / sponsor ID
- 111990-0104-3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Oct 2008 (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.
The purpose of this study was to assess PREVELLE Shape (CX002), with respect to safety and efficacy for one year following treatment, for correction of facial nasolabial folds and when applied as an intradermal implant for lip augmentation.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREVELLE Shape | Experimental | Device: PREVELLE Shape |
| Restylane | Active comparator | Device: Restylane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who gave written informed consent to participate.
- Male or female subjects aged between 30 and 60 years inclusive (nasolabial fold cohort) or male or female subjects 18 years of age and older (lip augmentation cohort).
- Subjects with NLFs that had shallow wrinkles, moderately deep wrinkles, or deep wrinkles with well defined edges (level 2, 3, or 4 on the six-point categorical rating scale), suitable for soft tissue augmentation or subjects who desired lip enlargement.
Key exclusion criteria (22 listed)
- Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
- Subjects with a known hypersensitivity to sodium hyaluronate, lidocaine, xylocaine, or epinephrine.
- Subjects with known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies.
- Subjects with any serious skin disease, e.g., Eczema and psoriasis of the face, severe rosacea, scleroderma, local infections and severe acne.
- Subjects with cancerous or precancerous lesions in either the right or left NLF or the lips.
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 |
|---|---|---|
| PREVELLE Shape | Device | PREVELLE Shape |
| Restylane | Device | Restylane |
Primary outcome
Study the safety and efficacy of CX002 when applied to the NLFs or lips.
Time frame: 1 year
The primary aim of the study is to assess CX002, with respect to safety and efficacy during the six months following treatment, in two subject cohorts: 1. When applied as an intradermal implant for the correction of facial nasolabial folds (Nasolabial Fold Cohort). Nasolabial folds were chosen as the fold/wrinkle for treatment as they are often the most severe facial wrinkles, representing a "worst-case" scenario 2. When applied as an intradermal implant for lip augmentation (Lip Augmentation Cohort)
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 20 Dec 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PREVELLE Shape and Restylane in people with Correction of Nasolabial Folds and Lip Augmentation, run by Mentor Worldwide, LLC at 1 site 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 3 inclusion and 22 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 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Study the safety and efficacy of CX002 when applied to the NLFs or lips. (time frame: 1 year). 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 20 Dec 2011.