Trial Outcomes & Findings for Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI (NCT NCT00922623)

Last Updated: 2013-04-26

Results Overview

Adverse events considered possibly, probably, or definitely related to study product are summarized by body system and MedDRA preferred term.

Recruitment status

COMPLETED

Study phase

Target enrollment

93 participants

Primary outcome timeframe

24 weeks

Results posted on

2013-04-26

Participant milestones
Measure	Belotero® Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
Overall Study STARTED	93
Overall Study COMPLETED	88
Overall Study NOT COMPLETED	5

Reasons for withdrawal
Measure	Belotero® Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
Overall Study Other	4
Overall Study Lost to Follow-up	1

Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI

Baseline characteristics by cohort
Measure	Belotero® n=93 Participants Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age Continuous	51.5 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	90 participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 participants n=5 Participants

Timeframe: 24 weeks

Population: The Full Analysis Set (FAS) consisted of all subjects enrolled and treated with Belotero (ITT principle).

Adverse events considered possibly, probably, or definitely related to study product are summarized by body system and MedDRA preferred term.

Outcome measures
Measure	Belotero, Left Nasolabial Fold n=93 Participants Belotero injected into the Left Nasolabial Fold of the Face	Belotero, Right Nasolabial Fold n=93 Participants Belotero injected into the Right Nasolabial Fold of the Face
Percentage of Subjects With Product-related Adverse Events.	71 percentage of subjects with AEs.	72 percentage of subjects with AEs.

Serious events: 0 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 72 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Belotero, Left Nasolabial Fold n=93 participants at risk	Belotero, Right Nasolabial Fold n=93 participants at risk
General disorders Injection site swelling	59.1% 55/93	60.2% 56/93
General disorders Injection site induration	54.8% 51/93	59.1% 55/93
General disorders Injection site pain	39.8% 37/93	50.5% 47/93
General disorders Injection site nodule	33.3% 31/93	40.9% 38/93
General disorders Injection site erythema	31.2% 29/93	31.2% 29/93
General disorders Injection site pruritus	20.4% 19/93	23.7% 22/93
General disorders Injection site bruising	15.1% 14/93	23.7% 22/93
General disorders Injection site discoloration	16.1% 15/93	20.4% 19/93

Phone: 650-286-4000

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