Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler

Completed · Phase 4

Conditions studied: Nasolabial Folds

In brief

To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.

Key facts

Study ID

NCT01012661

Run by

Merz North America, Inc.

People needed

50

Starts

2008-09-01

Expected to finish

2009-01-01

Last updated by the study team

2013-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is at least 18 years of age.
• Is a candidate for nasolabial fold treatment using Radiesse.
• Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month.
• Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
• Has approximately symmetrical nasolabial folds.

You may not qualify if…

• Has received any type of treatment or procedures including surgery in the nasolabial folds.
• Has received neurotoxins in the lower half of the face in the past 6 months.
• Has received hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 1 ½ years.
• Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other permanent filler in the lower half of the face.
• Has nasolabial folds that are too severe to be corrected in one treatment session.
• Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study.
• Has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding.
• Is female and of child bearing potential and is pregnant or not using acceptable method of birth control.
• Has had any history of hypersensitivity to Lidocaine or anesthetics of the amide type.
• Has a history of anaphylaxis or multiple severe allergies.
• Has received any investigational product within 30 days prior to study enrollment or is planning to participate in another investigation during the course of this study.

Where it is running

• Study site — Rockville, Maryland, United States
• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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