Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections - Full Text View

Sponsored by:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00716443

Purpose

Pliaglis® Cream vs BLT ointment for pain management during Restylane® injections for the correction of nasolabial folds.

Condition	Intervention	Phase
Nasolabial Folds	Drug: tetracaine 7%/lidocaine 7% cream & betacaine 20%/lidocaine 6%/tetracaine 4% ointment (Pliaglis® Cream)	Phase IV

Drug Information available for: Tetracaine Viractin Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Open-Label, Randomized, Split-Face Study to Evaluate the Efficacy, Safety and Subject Satisfaction of Pain Management During and After Restylane® Dermal Filler Injections for the Correction of Nasolabial Folds

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

Subject's Pain Evaluation by VAS scale [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject, Investigator and Blinded Observer questionnaires [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
Tolerability assessments, adverse events [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Enrollment:	57
Study Start Date:	July 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Apply tetracaine/lidocaine cream once on one side of the face and betacaine/lidocaine/tetracaine ointment once on the other side of the face prior to Restylane® injections

Detailed Description:

Open-label, randomized study designed to assess the effectiveness of a topical anesthetic (Pliaglis® Cream) versus a compounded topical anesthetic cream at needle stick, immediately after, one and three hours after Restylane® injections in the nasolabial folds.

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or Female Subjects 30 - 65 years of age
Subject undergoing cosmetic dermal filler injections for correction of nasolabial folds. Treatment sites should be comparable, requiring the same number of injections on each nasolabial fold
Subjects diagnosed with moderate nasolabial folds (Wrinkle Severity Rating Scale of grade 3)

Exclusion Criteria:

Subjects under treatment for a dermatologic condition on the face, which may interfere with the safe evaluation of the study treatment (e.g. eczema, psoriasis, severe sun-damage, dermatitis), have damaged, denuded or broken skin at the designated treatment site and/or have scarring or infection of the area to be treated
Subjects who have taken prescription or non-prescription analgesic medication during the 24 hour period prior to the procedure
Subjects with a history of bleeding or clotting disorders
Subjects who have used ASA, NSAIDs, anticoagulants, St. John's Wort or high doses of Vitamin E (above the recommended daily allowance) within 2 weeks prior to the procedure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716443

Locations

United States, Florida
Palm Beach Esthetic Dermatology and Laser Center
West Palm Beach, Florida, United States, 33401
Skin and Cancer Associates, Center for Cosmetic Enhancement
Aventura, Florida, United States, 33180
United States, New York
Sadick Dermatology
New York, New York, United States, 10021
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10098
Study First Received:	July 14, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00716443
Health Authority:	United States: Institutional Review Board

Keywords provided by Galderma Laboratories, L.P.:

Nasolabial folds
wrinkles
topical anesthetic

Study placed in the following topic categories:

Tetracaine
Facies
Lidocaine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009