Trial Outcomes & Findings for Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds (NCT NCT00414544)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

145 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2011-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	CosmetaLife vs Restylane 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 Study STARTED	145
Overall Study COMPLETED	131
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	CosmetaLife vs Restylane 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 Study Lost to Follow-up	14

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CosmetaLife vs Restylane n=145 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants
Age Continuous	53.9 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	145 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: 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)

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.

Outcome measures

Outcome measures
Measure	CosmetaLife n=140 Participants CosmetaLife injected nasolabial fold side	Restylane (Control) n=140 Participants Restylane (Control) injected nasolabial fold contralateral side
Change in Wrinkle Severity Rating Scale	-0.94 units on scale Standard Deviation 0.71	-1.07 units on scale Standard Deviation 0.76

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3, 9 and 12 months

Outcome measures

Outcome data not reported

Adverse Events

CosmetaLife

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Restylane (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David B. Masters

Cosmeta, A Gel-Del Technolgies Company

Phone: 651 209-0707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Study results were presented and published at national meetings. Standard confidentiality agreements were signed by PIs for company confidential information.
Publication restrictions are in place

Restriction type: OTHER