Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds

NCT00797459 | Completed Results

• 1 other identifier: MA-1100-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

Safety \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) 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 Pain as Measured by a Visual Analogue Scale

  No pain is noted at 0 mm and worst pain is noted at 100 mm.

  After Injection on Day of Treatment

Secondary Outcomes (1)

• Wrinkle Improvement at Day 14

  14 days after treatment when compared to baseline

Study Arms (1)

Restylane and Restylane with Lidocaine

EXPERIMENTAL

This is a split-face design injecting both Restylane and Restylane-L injectable gels, administered once. Each subject received Restylane on one side of the face, and Restylane-L on the other. Subjects were blinded to which side of their face received Restylane or Restylane-L. The study was randomized and treatments successive.

Device: Restylane and Restylane-L

Interventions

Restylane and Restylane-L DEVICE

This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.

Restylane and Restylane with Lidocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects seeking augmentation therapy for correction of bilateral NLFs
• Same WSRS score at both NLFs (either both Moderate \[3\] or both Severe \[4\])
• Subjects willing to give written informed consent to participate in the study
• Women of childbearing potential willing to use an acceptable form of birth control during the study period

You may not qualify if:

• Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
• 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 NLF area

Sponsors & Collaborators

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

Study Sites (3)

Dermatology Research Institute LLC

Coral Gables, Florida, 33146, United States

Location

Maryland Laser Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

The Center for Dermatology, Cosmetic and Laser Surgery

Mount Kisco, New York, 10549, United States

Location

Results Point of Contact

• Title: Ron Staugaard
• Organization: Medicis

rstaugaard@medicis.com

480-291-5652

Study Officials

• David Bank, MD

  The Center for Dermatology, Cosmetic and Laser Surgery

  PRINCIPAL INVESTIGATOR

• Fredric Brandt, MD

  Dermatology Research Institute LLC

  PRINCIPAL INVESTIGATOR

• Robert Weiss, MD

  Maryland Laser Skin and Vein Institute

  PRINCIPAL INVESTIGATOR

• Ron Staugaard

  Medicis Pharmaceutical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 6, 2013
• Results First Posted: February 21, 2011

Record last verified: 2013-08

Locations

US (3)