Evaluation of Pain With Lidocaine-Mixed RadiesseĀ® Injectable Dermal Filler (NCT01012661) | Clinical Trial Compass
CompletedPhase 4
Evaluation of Pain With Lidocaine-Mixed RadiesseĀ® Injectable Dermal Filler
United States50 participantsStarted 2008-09
Plain-language summary
To assess pain during nasolabial fold treatment using RadiesseĀ® Injectable Dermal Filler mixed with lidocaine.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 investigationā¦
What they're measuring
1
Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)
Timeframe: Immediately after injection (Time 0)
2
Patients With Clinically Significant Reduction in Pain