N/A
N=102
Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds
Nasolabial Folds
Bottom Line
View on ClinicalTrials.gov: NCT01069354 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain) — 2.32; 6.73 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiesse® Injectable Dermal Filler with Lidocaine (Device); Radiesse® Injectable Dermal Filler without Lidocaine (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merz North America, Inc.
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain) |
2.32; 6.73 | <0.0001 sig |
| SECONDARY Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS |
91 | <0.0001 sig |
| SECONDARY Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection |
1.06; 3.45 | <0.0001 sig |
| SECONDARY Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection |
0.73; 2.52 | <0.0001 sig |
| SECONDARY Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection |
0.48; 1.78 | <0.0001 sig |
| SECONDARY Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection |
0.31; 1.09 | <0.0001 sig |
| SECONDARY Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection |
0.05; 0.04 | 0.5663 |
| SECONDARY Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection |
0.01; 0 | 0.3197 |
| SECONDARY Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection |
0; 0 | — |
| SECONDARY Assess Subject Preference to Pain |
98; 87 | — |
Summary
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with lidocaine
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
Data sourced from ClinicalTrials.gov (NCT01069354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.