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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Medicis Global Service Corporation.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Medicis Global Service Corporation

ClinicalTrials.gov Identifier:

NCT00977704

First received: September 14, 2009

Last updated: January 4, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2009

Last Updated Date

January 4, 2010

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Local and systemic adverse events [ Time Frame: 2-weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00977704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

This is an open-label study of Restylane and Perlane in the correction of peri-oral wrinkles.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Peri-oral Wrinkles

Intervention ^ICMJE

Device: Perlane and Restylane

Perlane and Restylane

Study Arm (s)

Experimental: Perlane and Restylane

Perlane and Restylane used open label to correct peri-oral wrinkles

Intervention: Device: Perlane and Restylane

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00977704

Other Study ID Numbers ^ICMJE

MA-1900-01

Has Data Monitoring Committee

Responsible Party

Mary Sanstead, Clinical Study Manager, Medicis Global Services

Study Sponsor ^ICMJE

Medicis Global Service Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Mary Sanstead, RN, BSN, CCRC

Medicis Global Services

Information Provided By

Medicis Global Service Corporation

Verification Date

January 2010

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

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