Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

NCT01069354 | Completed Results

• 1 other identifier: P120677
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Nasolabial Folds

Keywords

Moderate to severe wrinkles and folds such as nasolabial folds

Outcome Measures

Primary Outcomes (1)

• Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain)

  Assessment of whether a statistically significant reduction in pain score in the Radiesse® Mixed with Lidocaine nasolabial fold was observed when compared to the Radiesse® without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (0 = no pain, 10 = very severe pain). In the study protocol, the assessment of achieving a statistically significant reduction in pain at time zero was selected a priori to be analyzed using a paired t-test to test the null hypothesis that the mean of the differences in VAS scores between the Treatment and Control folds is equal to zero.

  Immediately after injection (Time 0)

Secondary Outcomes (9)

• Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS

  Immediately after injection (Time 0)

• Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection

  15 minutes post injection

• Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection

  30 minutes post injection

• Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection

  45 minutes post injection

• Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection

  60 minutes post injection

Study Arms (2)

Radiesse® Mixed with Lidocaine

EXPERIMENTAL

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).

Device: Radiesse® Injectable Dermal Filler with Lidocaine

Radiesse® without Lidocaine

ACTIVE COMPARATOR

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).

Device: Radiesse® Injectable Dermal Filler without Lidocaine

Interventions

Radiesse® Injectable Dermal Filler with Lidocaine DEVICE

Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl)

Radiesse® Mixed with Lidocaine

Radiesse® Injectable Dermal Filler without Lidocaine DEVICE

Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)

Radiesse® without Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (2)

Unknown Facility

Toronto, Canada

Location

Unknown Facility

Woodbridge, Canada

Location

Related Publications (1)

• Schachter D, Bertucci V, Solish N. Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds. J Drugs Dermatol. 2016 Aug 1;15(8):1005-10.

  PMID: 27538003 RESULT

Results Point of Contact

• Title: Ashlee Duncan
• Organization: Merz North America, Inc.

ashlee.duncan@merz.com

984-222-6040

Study Officials

• Fred Derosier, DO

  Merz North America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 17, 2010
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: February 1, 2014
• Last Updated: May 30, 2018
• Results First Posted: May 30, 2018

Record last verified: 2017-09

Locations

CA (2)