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

Nasolabial Folds Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823069
• Other study ID #: MA-1400-03
• Status: Completed
• Phase: N/A
• First received: January 14, 2009
• Last updated: November 1, 2010
• Start date: January 2009
• Est. completion date: April 2009

Study information

• Verified date: November 2010
• Source: Medicis Global Service Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medicis Global Service Corporation	Q-Med Scandinavia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm		After Injection on Day of Treatment	No
Secondary	Number of Subjects Showing Wrinkle Improvement at Day 14	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.	14 days after treatment when compared to baseline	No