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

Nasolabial Folds Clinical Trial

Official title:

Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012661
• Other study ID #: P0408329
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2009
• Last updated: April 19, 2013
• Start date: September 2008
• Est. completion date: January 2009

Study information

• Verified date: April 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• Radiesse® Injectable Dermal Filler Mixed with Lidocaine
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)
• Radiesse® Injectable Dermal Filler without Lidocaine
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Marmur E, Green L, Busso M. Controlled, randomized study of pain levels in subjects treated with calcium hydroxylapatite premixed with lidocaine for correction of nasolabial folds. Dermatol Surg. 2010 Mar;36(3):309-15. doi: 10.1111/j.1524-4725.2009.01435. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Immediately after injection (Time 0)	No
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).	Immediately after injection (Time 0)	No