Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler

Merz Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Nasolabial Folds

Treatments: Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine; Device: Radiesse® Injectable Dermal Filler without Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012661

P0408329

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Radiesse® Mixed with Lidocaine

Experimental group

Description:

Injectable Dermal Filler. The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face).

Treatment:

Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine

Radiesse® without Lidocaine

Active Comparator group

Description:

Injectable Dermal Filler. The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face.

Treatment:

Device: Radiesse® Injectable Dermal Filler without Lidocaine