Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles
Phase 4
Completed
- Conditions
- Peri-oral Wrinkles
- Interventions
- Device: Restylane and Perlane
- Registration Number
- NCT00977704
- Lead Sponsor
- Medicis Global Service Corporation
- Brief Summary
This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Same Wrinkle Severity (either both Moderate [3] or both Severe [4]) of marionette lines and upper peri-oral rhytids
Exclusion Criteria
- Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
- Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry
- Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
- Permanent implant placed in the Nasolabial Fold area
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Restylane and Perlane Restylane and Perlane Restylane and Perlane administered by injection. Recommended volume of 6.0 mL. Injection on study day 1 with an optional touch up on study day 14.
- Primary Outcome Measures
Name Time Method Local and Systemic Adverse Events 2-weeks To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:
* All local adverse events as reported by healthcare professional
* All systemic adverse events (related and unrelated)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Call For Information
🇺🇸Dallas, Texas, United States