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Completed

NCT Number: NCT00823069

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

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

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Key information

Conditions

Nasolabial Folds

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coral Gables, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perlane and Perlane-L

Device

This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive.

Other names: Each subject received both Perlane-L and Perlane.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medicis Global Service Corporation

Industry

Collaborators

  • Q-Med Scandinavia, Inc.

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 15, 2009
Registry last updated
Nov 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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