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
1 other identifier
interventional
50
1 country
2
Brief Summary
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2008
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedResults Posted
Study results publicly available
January 15, 2010
CompletedApril 26, 2013
April 1, 2013
3 months
November 10, 2009
December 3, 2009
April 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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)
Study Arms (2)
Radiesse® Mixed with Lidocaine
EXPERIMENTALInjectable 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).
Radiesse® without Lidocaine
ACTIVE COMPARATORInjectable 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.
Interventions
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Rockville, Maryland, United States
Unknown Facility
New York, New York, United States
Related 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.x. Epub 2010 Jan 19.
PMID: 20100272RESULT
Results Point of Contact
- Title
- Merz Aesthetics, Inc.
- Organization
- Merz Aesthetics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 13, 2009
Study Start
September 1, 2008
Primary Completion
December 1, 2008
Study Completion
January 1, 2009
Last Updated
April 26, 2013
Results First Posted
January 15, 2010
Record last verified: 2013-04