Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles
An Open-label Study of the Safety of Restylane and Perlane in the Correction of Peri-oral Wrinkles.
1 other identifier
interventional
20
1 country
2
Brief Summary
This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2009
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 14, 2009
CompletedFirst Posted
Study publicly available on registry
September 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
June 10, 2013
CompletedJune 10, 2013
May 1, 2013
2 months
September 14, 2009
December 22, 2011
May 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local and Systemic Adverse Events
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)
2-weeks
Study Arms (1)
Restylane and Perlane
ACTIVE COMPARATORRestylane 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.
Interventions
Eligibility Criteria
You may qualify if:
- Same Wrinkle Severity (either both Moderate \[3\] or both Severe \[4\]) of marionette lines and upper peri-oral rhytids
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Call For Information
Coral Gables, Florida, 33146, United States
Call For Information
Dallas, Texas, 75254, United States
Results Point of Contact
- Title
- Head of Clinical Trials
- Organization
- Medicis R&D Clinical Research Department
Study Officials
- STUDY CHAIR
Mary Sanstead, RN, BSN, CCRC
Medicis Global Services
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2009
First Posted
September 16, 2009
Study Start
September 1, 2009
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
June 10, 2013
Results First Posted
June 10, 2013
Record last verified: 2013-05