Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

Merz Pharmaceuticals

Status: Completed

Conditions: Nasolabial Folds

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069354

P120677

Details and patient eligibility

About

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

Full 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

Enrollment: 102 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Radiesse® Mixed with Lidocaine

Experimental group

Description:

Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).

Treatment:

Device: Radiesse® Injectable Dermal Filler with Lidocaine

Radiesse® without Lidocaine

Active Comparator group

Description:

Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).

Treatment:

Device: Radiesse® Injectable Dermal Filler without Lidocaine