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

Peri-oral Wrinkles Clinical Trial

Official title:

An Open-label Study of the Safety of Restylane and Perlane in the Correction of Peri-oral Wrinkles.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977704
• Other study ID #: MA-1900-01
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2009
• Last updated: May 7, 2013
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2013
• Source: Medicis Global Service Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peri-oral Wrinkles

Intervention

Device:
• Restylane and Perlane

Locations

Country	Name	City	State
United States	Call For Information	Coral Gables	Florida
United States	Call For Information	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Medicis Global Service Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local and Systemic Adverse Events	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)	2-weeks	Yes