Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler
This study has been completed.
Sponsor:
Merz Pharmaceuticals, LLC
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
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Purpose
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.
| Condition | Intervention | Phase |
|---|---|---|
|
Nasolabial Folds |
Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine Device: Radiesse® Injectable Dermal Filler without Lidocaine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds |
Resource links provided by NLM:
Further study details as provided by Merz Pharmaceuticals, LLC:
Primary Outcome Measures:
- 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).
| Enrollment: | 50 |
| Study Start Date: | September 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)
|
|
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.
|
Device: Radiesse® Injectable Dermal Filler without Lidocaine
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
Publications:
| Responsible Party: | Merz Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT01012661 History of Changes |
| Other Study ID Numbers: | P0408329 |
| Study First Received: | November 10, 2009 |
| Results First Received: | December 3, 2009 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merz Pharmaceuticals, LLC:
|
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 Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013