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Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00977704
Recruitment Status : Completed
First Posted : September 16, 2009
Results First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Peri-oral Wrinkles Device: Restylane and Perlane Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : September 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: 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.
Device: Restylane and Perlane

Primary Outcome Measures :
  1. Local and Systemic Adverse Events [ Time Frame: 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00977704

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United States, Florida
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Coral Gables, Florida, United States, 33146
United States, Texas
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Dallas, Texas, United States, 75254
Sponsors and Collaborators
Medicis Global Service Corporation
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Study Chair: Mary Sanstead, RN, BSN, CCRC Medicis Global Services
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Responsible Party: Medicis Global Service Corporation Identifier: NCT00977704    
Other Study ID Numbers: MA-1900-01
First Posted: September 16, 2009    Key Record Dates
Results First Posted: June 10, 2013
Last Update Posted: June 10, 2013
Last Verified: May 2013
Keywords provided by Medicis Global Service Corporation:
Correction of peri-oral wrinkles