Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Medicis Global Service Corporation.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Medicis Global Service Corporation
Information provided by:
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT00977704
First received: September 14, 2009
Last updated: January 4, 2010
Last verified: January 2010
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Purpose
This is an open-label study of Restylane and Perlane in the correction of peri-oral wrinkles.
| Condition | Intervention |
|---|---|
|
Peri-oral Wrinkles |
Device: Perlane and Restylane |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Study of the Safety of Restylane and Perlane in the Correction of Peri-oral Wrinkles. |
Further study details as provided by Medicis Global Service Corporation:
Primary Outcome Measures:
- Local and systemic adverse events [ Time Frame: 2-weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Perlane and Restylane
Perlane and Restylane used open label to correct peri-oral wrinkles
|
Device: Perlane and Restylane
Perlane and Restylane
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977704
Locations
| United States, Florida | |
| Call For Information | |
| Coral Gables, Florida, United States, 33146 | |
| United States, Texas | |
| Call For IInformation | |
| Dallas, Texas, United States, 75254 | |
Sponsors and Collaborators
Medicis Global Service Corporation
Investigators
| Study Chair: | Mary Sanstead, RN, BSN, CCRC | Medicis Global Services |
More Information
No publications provided
| Responsible Party: | Mary Sanstead, Clinical Study Manager, Medicis Global Services |
| ClinicalTrials.gov Identifier: | NCT00977704 History of Changes |
| Other Study ID Numbers: | MA-1900-01 |
| Study First Received: | September 14, 2009 |
| Last Updated: | January 4, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medicis Global Service Corporation:
|
Correction of peri-oral wrinkles |
ClinicalTrials.gov processed this record on May 16, 2013