Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
Stopped early · Phase 4
Conditions studied: Nasolabial Folds
In brief
Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.
Key facts
- Study ID
- NCT00716443
- Run by
- Galderma R&D
- People needed
- 51
- Starts
- 2008-07-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2022-08-23
Who can join
Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- Skin and Cancer Associates, Center for Cosmetic Enhancement — Aventura, Florida, United States
- Palm Beach Esthetic Dermatology and Laser Center — West Palm Beach, Florida, United States
- Sadick Dermatology — New York, New York, United States
- Premier Clinical Research — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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