Clinical trial NCT01069354: Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds
Official title: Evaluation of Pain With the Use of Radiesse® With Lidocaine for the Treatment of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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: 2010-02-17
Enrollment: 102
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 with lidocaine

Detailed description: To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler 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
* Has approximately symmetrical nasolabial folds
* Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month

Exclusion Criteria:

* Has received any type of treatment or procedures including surgery in the nasolabial folds
* Has received neurotoxin, hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 6 months
* 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 any history of hypersensitivity to lidocaine or anesthetics of the amide type

Primary outcomes:
measure: Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain)
timeFrame: Immediately after injection (Time 0)
Secondary outcomes:
measure: Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS
timeFrame: Immediately after injection (Time 0)
measure: Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection
timeFrame: 15 minutes post injection
measure: Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection
timeFrame: 30 minutes post injection
measure: Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection
timeFrame: 45 minutes post injection
measure: Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection
timeFrame: 60 minutes post injection
measure: Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection
timeFrame: 1 week post injection
measure: Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection
timeFrame: 2 weeks post injection
measure: Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection
timeFrame: 4 weeks post injection
measure: Assess Subject Preference to Pain
timeFrame: Immediately after injection (Time 0)
Other outcomes:
Locations:
city: Toronto
country: Canada
city: Woodbridge
country: Canada
Study officials:
affiliation: Merz North America, Inc.
name: Fred Derosier, DO
role: STUDY_DIRECTOR
References:
citation: Schachter D, Bertucci V, Solish N. Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds. J Drugs Dermatol. 2016 Aug 1;15(8):1005-10.