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Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds

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ClinicalTrials.gov Identifier: NCT00414544
Recruitment Status : Completed
First Posted : December 21, 2006
Results First Posted : June 10, 2011
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
Cosmeta Corp, A Gel-Del Technologies Company
Information provided by:
Cosmeta

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Facial Wrinkles
Interventions Device: CosmetaLife
Device: Restylane
Enrollment 145
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CosmetaLife vs Restylane
Hide Arm/Group Description Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
Period Title: Overall Study
Started 145
Completed 131
Not Completed 14
Reason Not Completed
Lost to Follow-up             14
Arm/Group Title CosmetaLife vs Restylane
Hide Arm/Group Description Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
Overall Number of Baseline Participants 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants
<=18 years
0
   0.0%
Between 18 and 65 years
122
  84.1%
>=65 years
23
  15.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants
53.9  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants
Female
135
  93.1%
Male
10
   6.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 145 participants
145
1.Primary Outcome
Title Change in Wrinkle Severity Rating Scale
Hide Description To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat (ITT) and each subject received both CosmetaLife and Control (Restylane) injections into contralateral nasolabial folds, respectively. WSRS units (change from baseline analyzed)
Arm/Group Title CosmetaLife Restylane (Control)
Hide Arm/Group Description:
CosmetaLife injected nasolabial fold side
Restylane (Control) injected nasolabial fold contralateral side
Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: units on scale
-0.94  (0.71) -1.07  (0.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CosmetaLife, Restylane (Control)
Comments The a priori hypothesis for statistical analysis was based on predetermined clinical relevance being set to a difference score between CosmetaLife and Control (Restylane) of -0.5. This clinical relevance was set to -0.5 because the observation scale used is not accurate below 0.5 differences. That is CosmetaLife needed to be greater than 0.5 less than Control (Restylane) in the treatment difference scores to be considered inferior.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority was tested.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Confidence interval
Comments The 90% lower confidence bound of the difference between CosmetaLife and Restylane were computed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval (2-Sided) 90%
-2.0 to 1.0
Parameter Dispersion
Type: Standard Deviation
Value: 0.60
Estimation Comments The confidence interval is built around the mean difference of the two reporting groups.
2.Primary Outcome
Title Adverse Event Reporting
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months
Hide Description [Not Specified]
Time Frame 3, 9 and 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CosmetaLife Restylane (Control)
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
CosmetaLife Restylane (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CosmetaLife Restylane (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/145 (0.00%)   0/145 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
CosmetaLife Restylane (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/145 (0.00%)   0/145 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Study results were presented and published at national meetings. Standard confidentiality agreements were signed by PIs for company confidential information.
Results Point of Contact
Name/Title: Dr. David B. Masters
Organization: Cosmeta, A Gel-Del Technolgies Company
Phone: 651 209-0707
Responsible Party: David B. Masters/President, Cosmeta Corp, A Gel-Del Technologies Company
ClinicalTrials.gov Identifier: NCT00414544     History of Changes
Other Study ID Numbers: CosmetaLife 1
First Submitted: December 20, 2006
First Posted: December 21, 2006
Results First Submitted: March 4, 2011
Results First Posted: June 10, 2011
Last Update Posted: June 27, 2011