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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00977704
First Posted: September 16, 2009
Last Update Posted: June 10, 2013
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.
Information provided by (Responsible Party):
Medicis Global Service Corporation
September 14, 2009
September 16, 2009
December 22, 2011
June 10, 2013
June 10, 2013
September 2009
November 2009   (Final data collection date for primary outcome measure)
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)
Local and Systemic Adverse Events [ Time Frame: 2-weeks ]
Complete list of historical versions of study NCT00977704 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peri-oral Wrinkles
Device: Restylane and Perlane
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.
Intervention: Device: Restylane and Perlane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00977704
MA-1900-01
No
Not Provided
Not Provided
Medicis Global Service Corporation
Medicis Global Service Corporation
Not Provided
Study Chair: Mary Sanstead, RN, BSN, CCRC Medicis Global Services
Medicis Global Service Corporation
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP