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

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ClinicalTrials.gov 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):

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Primary Completion Date : November 2009
Study Completion Date : December 2009
Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00977704

United States, Florida
Call For Information
Coral Gables, Florida, United States, 33146
United States, Texas
Call For Information
Dallas, Texas, United States, 75254
Sponsors and Collaborators
Medicis Global Service Corporation
Study Chair: Mary Sanstead, RN, BSN, CCRC Medicis Global Services
More Information

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT00977704     History of Changes
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

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents