Clinical trial NCT01012661: Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler
Official title: Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasolabial Folds
Keywords: Moderate to severe wrinkles and folds such as nasolabial folds
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler mixed with lidocaine in one nasolabial fold compared to Radiesse® Injectable Dermal Filler without lidocaine in the contralateral nasolabial fold.

Eligibility criteria: 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 investigational product within 30 days prior to study enrollment or is planning to participate in another investigation during the course of this study.

Primary outcomes:
measure: Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)
timeFrame: Immediately after injection (Time 0)
measure: Patients With Clinically Significant Reduction in Pain
timeFrame: Immediately after injection (Time 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
state: Maryland
city: New York
country: United States
state: New York
Study officials:
References:
citation: Marmur E, Green L, Busso M. Controlled, randomized study of pain levels in subjects treated with calcium hydroxylapatite premixed with lidocaine for correction of nasolabial folds. Dermatol Surg. 2010 Mar;36(3):309-15. doi: 10.1111/j.1524-4725.2009.01435.x. Epub 2010 Jan 19.