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Keep this study
Lead
Galderma R&D
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 hours after Restylane® injections in the nasolabial folds.
Age
30–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
