Nasolabial Folds
Conditions
Keywords
Moderate to severe wrinkles and folds such as nasolabial folds
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.
Interventions
DEVICERadiesse® Injectable Dermal Filler Mixed with Lidocaine
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain) | Immediately after injection (Time 0) | Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain). |
| Patients With Clinically Significant Reduction in Pain | Immediately after injection (Time 0) | Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with \>/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl) | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age Continuous | 53 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 50 | 45 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)
Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).
Time frame: Immediately after injection (Time 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Mixed With Lidocaine | Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain) | 2.8 cm | Standard Deviation 1.9 |
| Radiesse® Without Lidocaine | Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain) | 6.6 cm | Standard Deviation 2.2 |
Primary
Patients With Clinically Significant Reduction in Pain
Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with \>/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain).
Time frame: Immediately after injection (Time 0)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiesse® Mixed With Lidocaine | Patients With Clinically Significant Reduction in Pain | 45 Participants |
| Radiesse® Without Lidocaine | Patients With Clinically Significant Reduction in Pain | 0 Participants |