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
  Purpose

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


Condition Intervention
Nasolabial Folds
Device: Perlane and Perlane-L

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Medicis Global Service Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823069

Locations
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.
Investigators
Study Chair: Mary Sanstead Medicis Global Pharmaceutical
  More Information

No publications provided

Responsible Party: Mary Sanstead, Clinical Study Manager, Medicis Global Services
ClinicalTrials.gov Identifier: NCT00823069     History of Changes
Other Study ID Numbers: MA-1400-03
Study First Received: January 14, 2009
Results First Received: August 25, 2010
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 20, 2014