Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose

This study has been completed.
Sponsor:
Collaborator:
Q-Med Scandinavia, Inc.
Information provided by:
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT00823069
First received: January 14, 2009
Last updated: November 1, 2010
Last verified: November 2010

January 14, 2009
November 1, 2010
January 2009
March 2009   (final data collection date for primary outcome measure)
Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm [ Time Frame: After Injection on Day of Treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00823069 on ClinicalTrials.gov Archive Site
Number of Subjects Showing Wrinkle Improvement at Day 14 [ Time Frame: 14 days after treatment when compared to baseline ] [ Designated as safety issue: No ]
This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.
Not Provided
Not Provided
Not Provided
 
Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Perlane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds

Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.

This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nasolabial Folds
Device: Perlane and Perlane-L
This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive.
Other Name: Each subject received both Perlane-L and Perlane.
Perlane and Perlane-L
This is a split-face design injecting both Perlane and Perlane-L injectable gels, administered once. Each subject received Perlane-L on one side of the face, and Perlane on the other. Subjects were blinded to which side of their face receive Perlane or Perlane-L. The study was randomized and treatments successive.
Intervention: Device: Perlane and Perlane-L
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate [3] or both Severe [4])

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
 
NCT00823069
MA-1400-03
No
Mary Sanstead, Clinical Study Manager, Medicis Global Services
Medicis Global Service Corporation
Q-Med Scandinavia, Inc.
Study Chair: Mary Sanstead Medicis Global Pharmaceutical
Medicis Global Service Corporation
November 2010

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