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
30 Years
65 Years
Both
Nasolabial Folds
Trial Information
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
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.
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 (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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds
Outcome Description:
Subject's pain as evaluated using a VAS scale from 0 - 10 cm (centimeters) with 0 cm being no pain and 10 cm being the worst pain imaginable upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds
Outcome Time Frame:
upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds
Safety Issue:
No
Principal Investigator
Ronald W Gottschalk, MD
Investigator Role:
Study Director
Investigator Affiliation:
Galderma Laboratories, L.P.
Authority:
United States: Institutional Review Board
Study ID:
US10098
NCT ID:
NCT00716443
Start Date:
July 2008
Completion Date:
September 2008
Related Keywords:
- Nasolabial Folds
- Nasolabial folds
- wrinkles
- topical anesthetic
Name | Location |
|---|---|
| Premier Clinical Research | Spokane, Washington 99204 |
| Skin and Cancer Associates, Center for Cosmetic Enhancement | Aventura, Florida 33180 |
| Palm Beach Esthetic Dermatology and Laser Center | West Palm Beach, Florida 33401 |
| Sadick Dermatology | New York, New York 10021 |
