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Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

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ClinicalTrials.gov Identifier: NCT01069354
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

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

Condition or disease Intervention/treatment Phase
Nasolabial Folds Device: Radiesse® Injectable Dermal Filler with Lidocaine Device: Radiesse® Injectable Dermal Filler without Lidocaine Not Applicable

Detailed 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Pain With the Use of Radiesse® With Lidocaine for the Treatment of Nasolabial Folds
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiesse® Mixed with Lidocaine
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
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl)

Active Comparator: Radiesse® without Lidocaine
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
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)




Primary Outcome Measures :
  1. Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain) [ Time Frame: Immediately after injection (Time 0) ]

    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.



Secondary Outcome Measures :
  1. Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS [ Time Frame: Immediately after injection (Time 0) ]
    In this split-face study, a clinically meaningful difference in pain was defined as a 2-cm "reduction" (i.e., subject reports at least 2-cm less pain on a 10-cm VAS) in the Radiesse® Mixed with Lidocaine NLF when compared to the Radiesse® without Lidocaine NLF.

  2. Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection [ Time Frame: 15 minutes post injection ]
    A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.

  3. Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection [ Time Frame: 30 minutes post injection ]
    A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.

  4. Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection [ Time Frame: 45 minutes post injection ]
    A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.

  5. Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection [ Time Frame: 60 minutes post injection ]
    A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.

  6. Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection [ Time Frame: 1 week post injection ]
    A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.

  7. Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection [ Time Frame: 2 weeks post injection ]
    A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.

  8. Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection [ Time Frame: 4 weeks post injection ]
    A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.

  9. Assess Subject Preference to Pain [ Time Frame: Immediately after injection (Time 0) ]

    2 questions were asked of 101 subjects: 1) Was one treatment less painful than the other? and 2) Was the difference in pain levels significant enough to affect your preference for one treatment over the other?

    Only those participants responding "yes" to these 2 questions about pain and preference for treatment are reported in the table below.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069354


Locations
Canada
Toronto, Canada
Woodbridge, Canada
Sponsors and Collaborators
Merz North America, Inc.
Investigators
Study Director: Fred Derosier, DO Merz North America, Inc.

Publications of Results:
Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT01069354     History of Changes
Other Study ID Numbers: P120677
First Posted: February 17, 2010    Key Record Dates
Results First Posted: May 30, 2018
Last Update Posted: May 30, 2018
Last Verified: September 2017

Keywords provided by Merz North America, Inc.:
Moderate to severe wrinkles and folds such as nasolabial folds

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action