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

September 14, 2009
May 7, 2013
September 2009
November 2009   (final data collection date for primary outcome measure)
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)
Local and systemic adverse events [ Time Frame: 2-weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00977704
MA-1900-01
No
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