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

NCT00823069 | Completed Results

• 1 other identifier: MA-1400-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Nasolabial Folds

Keywords

Correction of Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm

  After Injection on Day of Treatment

Secondary Outcomes (1)

• Number of Subjects Showing Wrinkle Improvement at Day 14

  14 days after treatment when compared to baseline

Study Arms (1)

Perlane and Perlane-L

OTHER

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

Interventions

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.

Also known as: Each subject received both Perlane-L and Perlane.

Perlane and Perlane-L

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medicis Global Service Corporation: lead
• Q-Med Scandinavia, Inc.: collaborator

Study Sites (3)

Unknown Facility

Coral Gables, Florida, United States

Location

Unknown Facility

Hunt Valley, Maryland, United States

Location

Unknown Facility

Mount Cisco, New York, United States

Location

Results Point of Contact

• Title: Mary Sanstead
• Organization: Medicis

msanstead@medicis.com

480-291-5926

Study Officials

• Mary Sanstead

  Medicis Global Pharmaceutical

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 30, 2010
• Results First Posted: November 30, 2010

Record last verified: 2010-11

Locations

US (3)