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

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. Identifier: NCT00823069
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : November 30, 2010
Last Update Posted : November 30, 2010
Q-Med Scandinavia, Inc.
Information provided by:
Medicis Global Service Corporation

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

Condition or disease Intervention/treatment Phase
Nasolabial Folds Device: Perlane and Perlane-L Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine
U.S. FDA Resources

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm [ Time Frame: After Injection on Day of Treatment ]

Secondary Outcome Measures :
  1. Number of Subjects Showing Wrinkle Improvement at Day 14 [ Time Frame: 14 days after treatment when compared to baseline ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00823069

United States, Florida
Coral Gables, Florida, United States
United States, Maryland
Hunt Valley, Maryland, United States
United States, New York
Mount Cisco, New York, United States
Sponsors and Collaborators
Medicis Global Service Corporation
Q-Med Scandinavia, Inc.
Study Chair: Mary Sanstead Medicis Global Pharmaceutical

Responsible Party: Mary Sanstead, Clinical Study Manager, Medicis Global Services Identifier: NCT00823069     History of Changes
Other Study ID Numbers: MA-1400-03
First Posted: January 15, 2009    Key Record Dates
Results First Posted: November 30, 2010
Last Update Posted: November 30, 2010
Last Verified: November 2010

Keywords provided by Medicis Global Service Corporation:
Correction of Nasolabial Folds

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action