Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
INTERVENTIONAL
2004-10-31
2007-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PREVELLE Shape
PREVELLE Shape
Restylane
Restylane
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PREVELLE Shape
Restylane
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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).
3. 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
2. Subjects with a known hypersensitivity to sodium hyaluronate, lidocaine, xylocaine, or epinephrine.
3. Subjects with known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies.
4. Subjects with any serious skin disease, e.g., Eczema and psoriasis of the face, severe rosacea, scleroderma, local infections and severe acne.
5. Subjects with cancerous or precancerous lesions in either the right or left NLF or the lips.
6. Subjects with diabetes, coagulation disorders, connective tissue disorders, lipodystrophy, or other serious systemic disease.
7. Subjects with active herpes labialis.
8. Subjects infected with HIV and/or who received immunosuppressive therapy.
9. Subjects who received injections of resorbable tissue augmentation materials to the NLFs or the lips within 18 months prior to baseline.
10. Subjects who received permanent tissue implant materials to the NLFs or the lips.
11. Subjects who received any experimental drug or device within the previous three months.
12. 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
13. Subjects who were to undergo major facial plastic surgery (e.g. rhinoplasty with or without implant, eyelid lift, facelift, etc).
14. Subjects who were known alcohol or drug abusers.
15. 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.
16. 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.
17. Worked for Mentor or the study Investigator or were directly-related to anyone that worked for Mentor or the study doctor.
18. Subjects requiring facial soft tissue augmentation because of traumatic injury (nasolabial fold cohort only).
19. 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).
20. Subjects who were treated with Retin-A four weeks prior to the baseline visit (nasolabial fold cohort only).
21. Subjects who were treated with Botox anywhere on the face within six months prior to the baseline visit (nasolabial fold cohort only).
22. Subjects who received laser resurfacing anywhere on the face within 12 months prior to the baseline visit (nasolabial fold cohort only).
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mentor Worldwide, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mentor Worldwide, LLC
Santa Barbara, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
111990-0104-3
Identifier Type: -
Identifier Source: org_study_id