Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Merz North America, Inc.
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported