Trial Outcomes & Findings for Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®. (NCT NCT00876265)

Last Updated: 2013-04-26

Results Overview

The severity of the nasolabial folds was measured using the wrinkle Severity Rating Scale (SRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

118 participants

Primary outcome timeframe

Baseline and Week 12 of follow-up

Results posted on

2013-04-26

Participant Flow

The subjects in this trial were enrolled from six study centers in the United States between November 2006 and July 2007. Subjects were males or non-pregnant females aged 18 to 75 years and who had bilateral nasolabial folds with a severity of 2 or 3 (moderate to severe).

The planned enrollment was 120 subjects; 118 subjects were randomized.

Participant milestones

Participant milestones
Measure	Overall Study
Overall Study STARTED	118
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Study
Overall Study Miscellaneous reasons	4
Overall Study Lost to Follow-up	6
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=118 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	110 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age Continuous	52.4 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12 of follow-up

Population: The Full Analysis Set (FAS) population was the analysis population which was defined as all subjects who were randomized and received at least one injection of the study device to the nasolabial folds.

The severity of the nasolabial folds was measured using the wrinkle Severity Rating Scale (SRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale.

Outcome measures

Outcome measures
Measure	Belotero n=118 Participants Belotero was injected into the left or right nasolabial fold using a randomization schedule.	Zyplast n=118 Participants Zyplast was injected into the opposite nasolabial fold that Belotero was injected into.
Adjusted (LS) Mean Change From Baseline in Wrinkle Severity Rating Scale (SRS) Score of Each Nasolabial Fold (NLF) as Determined by the Blinded Evaluator at Week 12.	1.224 Wrinkle Severity Rating Score (SRS) Standard Error 0.111 • Interval -0.228 to 0.323	1.176 Wrinkle Severity Rating Score (SRS) Standard Error 0.111

Adverse Events

Belotero

Serious events: 0 serious events

Other events: 108 other events

Deaths: 0 deaths

Zyplast

Serious events: 0 serious events

Other events: 109 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Belotero n=118 participants at risk	Zyplast n=118 participants at risk
General disorders Injection site erythema	56.8% 67/118	63.6% 75/118
General disorders Injection site swelling	50.0% 59/118	51.7% 61/118
General disorders Injection site bruising	55.9% 66/118	43.2% 51/118
General disorders Injection site pain	41.5% 49/118	49.2% 58/118
General disorders Injection site discoloration	23.7% 28/118	26.3% 31/118
General disorders Injection site pruritus	13.6% 16/118	20.3% 24/118
General disorders Injection site induration	8.5% 10/118	11.9% 14/118
Gastrointestinal disorders Injection site nodule	6.8% 8/118	12.7% 15/118

Additional Information

Merz Aesthetics, Inc.

Phone: 650-286-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any proposed press release, announcement, disclosure for publication, whether or not in writing, prepared by or on behalf of Consultant as part of services under this Agreement or that relates to the work performed hereunder must be reviewed and approved in writing by Merz prior to dissemination.
Publication restrictions are in place

Restriction type: OTHER