Trial Outcomes & Findings for Belotero Post Approval Study (NCT NCT01635855)

Last Updated: 2014-07-04

Results Overview

The purpose of this study was to determine if the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in the Belotero® Balance IDE clinical trial and Belotero® Balance Fitzpatrick Skin Type IV-VI Study (Pre-Approval Studies)."Common" is defined as pre-specified adverse events occurring in \>= 5% of study subjects. These averse events are: bruising, itching, pain, redness, swelling, discoloration, nodule, and induration.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

117 participants

Primary outcome timeframe

1 month

Results posted on

2014-07-04

Participant Flow

Participant milestones

Participant milestones
Measure	Belotero®: Hyaluronic Acid Dermal Filler Belotero®: Hyaluronic acid dermal filler
Overall Study STARTED	117
Overall Study COMPLETED	113
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Belotero®: Hyaluronic Acid Dermal Filler Belotero®: Hyaluronic acid dermal filler
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Belotero Post Approval Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belotero®: Hyaluronic Acid Dermal Filler n=117 Participants Belotero®: Hyaluronic acid dermal filler
Age, Continuous	57.04 years STANDARD_DEVIATION 9.40 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	117 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure	Belotero n=117 Participants Belotero®: Hyaluronic acid dermal filler
Rate of Severe Common Adverse Events	8.5 percentage of 'severe' common AEs Interval 3.5 to 13.6

Adverse Events

Belotero®: Hyaluronic Acid Dermal Filler

Serious events: 0 serious events

Other events: 100 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Belotero®: Hyaluronic Acid Dermal Filler n=117 participants at risk Belotero®: Hyaluronic acid dermal filler
Skin and subcutaneous tissue disorders Bruising	66.7% 78/117 • The purpose of this study was to determine the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in Belotero Balance IDE and Belotero Balance Fitzpatrick Skin Type IV-VI Study.
Skin and subcutaneous tissue disorders Itching	26.5% 31/117 • The purpose of this study was to determine the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in Belotero Balance IDE and Belotero Balance Fitzpatrick Skin Type IV-VI Study.
Skin and subcutaneous tissue disorders Pain	37.6% 44/117 • The purpose of this study was to determine the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in Belotero Balance IDE and Belotero Balance Fitzpatrick Skin Type IV-VI Study.
Skin and subcutaneous tissue disorders Redness	58.1% 68/117 • The purpose of this study was to determine the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in Belotero Balance IDE and Belotero Balance Fitzpatrick Skin Type IV-VI Study.
Skin and subcutaneous tissue disorders Swelling	67.5% 79/117 • The purpose of this study was to determine the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in Belotero Balance IDE and Belotero Balance Fitzpatrick Skin Type IV-VI Study.
Skin and subcutaneous tissue disorders Discoloration	39.3% 46/117 • The purpose of this study was to determine the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in Belotero Balance IDE and Belotero Balance Fitzpatrick Skin Type IV-VI Study.
Skin and subcutaneous tissue disorders Nodule	34.2% 40/117 • The purpose of this study was to determine the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in Belotero Balance IDE and Belotero Balance Fitzpatrick Skin Type IV-VI Study.
Skin and subcutaneous tissue disorders Induration	16.2% 19/117 • The purpose of this study was to determine the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in Belotero Balance IDE and Belotero Balance Fitzpatrick Skin Type IV-VI Study.
Investigations Needle Jam	16.2% 19/117 • The purpose of this study was to determine the rate of "Severe" common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in Belotero Balance IDE and Belotero Balance Fitzpatrick Skin Type IV-VI Study.

Additional Information

Merz Pharmaceuticals North America

Phone: 800-334-0514

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No manuscripts may be submitted for publication without prior review by the Sponsor. Investigator agrees to accommodate requests by Sponsor to protect proprietary rights/interests. Sponsor will be given full credit/acknowledgment for support provided for any publication resulting from this research. Investigator shall grant to the Sponsor an irrevocable royalty free, non-exclusive right to reproduce, translate, use all such copyrighted material arising from publications from study.
Publication restrictions are in place

Restriction type: OTHER