Status:
TERMINATED
Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
Lead Sponsor:
Galderma R&D
Conditions:
Nasolabial Folds
Eligibility:
All Genders
30-65 years
Phase:
PHASE4
Brief Summary
Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.
Detailed Description
Open-label, randomized study designed to assess the effectiveness of a topical anesthetic (Pliaglis® Cream) versus a compounded topical anesthetic at needle stick, immediately after, one and three hou...
Eligibility Criteria
Inclusion
- 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
- 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 (aspirin), NSAIDs (Non-Steroidal Anti- inflammatory Drugs), anticoagulants, St. John's Wort or high doses of Vitamin E (above the recommended daily allowance) within 2 weeks prior to the procedure
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00716443
Start Date
July 1 2008
End Date
September 1 2008
Last Update
August 23 2022
Active Locations (4)
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1
Skin and Cancer Associates, Center for Cosmetic Enhancement
Aventura, Florida, United States, 33180
2
Palm Beach Esthetic Dermatology and Laser Center
West Palm Beach, Florida, United States, 33401
3
Sadick Dermatology
New York, New York, United States, 10021
4
Premier Clinical Research
Spokane, Washington, United States, 99204