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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


Phase 4
30 Years
65 Years
Not Enrolling
Both
Nasolabial Folds

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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 ResearchSpokane, Washington  99204
Skin and Cancer Associates, Center for Cosmetic EnhancementAventura, Florida  33180
Palm Beach Esthetic Dermatology and Laser CenterWest Palm Beach, Florida  33401
Sadick DermatologyNew York, New York  10021