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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT00977704
First received: September 14, 2009
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.


Condition Intervention Phase
Peri-oral Wrinkles
Device: Restylane and Perlane
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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: Yes ]

    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)


Enrollment: 20
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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, see Learn About Clinical Studies.

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 Information
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: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT00977704     History of Changes
Other Study ID Numbers: MA-1900-01
Study First Received: September 14, 2009
Results First Received: December 22, 2011
Last Updated: May 7, 2013
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 July 22, 2014