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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01012661
First received: November 10, 2009
Last updated: April 19, 2013
Last verified: April 2013

November 10, 2009
April 19, 2013
September 2008
December 2008   (final data collection date for primary outcome measure)
  • Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain) [ Time Frame: Immediately after injection (Time 0) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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).
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Complete list of historical versions of study NCT01012661 on ClinicalTrials.gov Archive Site
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Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler
Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Nasolabial Folds
  • Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine
    Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)
  • Device: Radiesse® Injectable Dermal Filler without Lidocaine
    Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
  • Experimental: Radiesse® Mixed with Lidocaine
    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).
    Intervention: Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine
  • Active Comparator: Radiesse® without Lidocaine
    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.
    Intervention: Device: Radiesse® Injectable Dermal Filler without Lidocaine
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.x. Epub 2010 Jan 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01012661
P0408329
No
Merz Pharmaceuticals, LLC
Merz Pharmaceuticals, LLC
Not Provided
Not Provided
Merz Pharmaceuticals, LLC
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP