- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00764257
PREVELLE Shape (CX002) Dermal Filler Protocol
December 19, 2011 updated by: Mentor Worldwide, LLC
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Santa Barbara, California, United States, 93111
- Mentor Worldwide, LLC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PREVELLE Shape
|
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ACTIVE_COMPARATOR: Restylane
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (ACTUAL)
January 1, 2007
Study Completion (ACTUAL)
January 1, 2007
Study Registration Dates
First Submitted
October 1, 2008
First Submitted That Met QC Criteria
October 1, 2008
First Posted (ESTIMATE)
October 2, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
December 20, 2011
Last Update Submitted That Met QC Criteria
December 19, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 111990-0104-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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