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Completed

NCT Number: NCT01069354

Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

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

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Key information

Conditions

Nasolabial Folds

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiesse® Injectable Dermal Filler with Lidocaine

Device

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

Radiesse® Injectable Dermal Filler without Lidocaine

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

Evaluation of Pain With the Use of Radiesse® With Lidocaine for the Treatment of Nasolabial Folds

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Feb 17, 2010
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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