Trial Outcomes & Findings for Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement (NCT NCT01579305)

Results Overview

The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

285 participants

Primary outcome timeframe

3 months

Results posted on

2019-01-17

Participant Flow

Enrollment was defined as having signed the IRB-approved Informed Consent Form. Prior to randomization, 4 subjects were excluded as screen fails, leaving an "Intent-to-Treat" population of 281 subjects.

Participant milestones

Participant milestones
Measure	Subject Randomized to Receive VOLBELLA®	Subjects Randomized to Receive Restylane-L®
Overall Study STARTED	139	142
Overall Study Discontinued Before Treatment	0	1
Overall Study Continued After Treatment	139	141
Overall Study COMPLETED	118	115
Overall Study NOT COMPLETED	21	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Randomized to Receive VOLBELLA® n=139 Participants	Subjects Randomized to Receive Restylane-L® n=141 Participants	Total n=280 Participants Total of all reporting groups
Age, Continuous	47.1 years STANDARD_DEVIATION 11.94 • n=5 Participants	48.3 years STANDARD_DEVIATION 12.61 • n=7 Participants	47.7 years STANDARD_DEVIATION 12.28 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants	139 Participants n=7 Participants	274 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment France	48 participants n=5 Participants	49 participants n=7 Participants	97 participants n=5 Participants
Region of Enrollment United Kingdom	91 participants n=5 Participants	92 participants n=7 Participants	183 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Per-protocol population (all subjects who are randomized, received at least 1 study treatment, and have no protocol deviations that affect the primary effectiveness endpoint)

The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).

Outcome measures

Outcome measures
Measure	Subjects Randomized to Receive VOLBELLA® and Treated n=123 Participants	Subjects Randomized to Receive Restylane-L® and Treated n=123 Participants
Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment	34.1 Percentage of subjects Interval 25.77 to 42.53	29.3 Percentage of subjects Interval 21.23 to 37.31

Adverse Events

Subjects Treated With VOLBELLA®

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Subjects Treated With Restylane-L®

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Subjects Treated With VOLBELLA® n=139 participants at risk	Subjects Treated With Restylane-L® n=141 participants at risk
Injury, poisoning and procedural complications Tendon rupture	0.72% 1/139	0.00% 0/141
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/139	0.71% 1/141

Other adverse events

Other adverse events
Measure	Subjects Treated With VOLBELLA® n=139 participants at risk	Subjects Treated With Restylane-L® n=141 participants at risk
General disorders Injection site mass	10.1% 14/139	8.5% 12/141
General disorders Injection site pain	3.6% 5/139	6.4% 9/141
Infections and infestations Oral herpes	7.9% 11/139	5.0% 7/141

Additional Information

Medical Monitor

Allergan, Inc.

Phone: 805 961 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Allergan, as the Sponsor, has proprietary interest in this study. Authorship and manuscript composition will reflect joint cooperation between multiple Investigators and sites and Allergan personnel. Authorship will be established prior to the writing of the manuscript. As this study involves multiple centers, no individual publications will be allowed prior to completion of the final report of the multicenter study except as agreed with Allergan.
Publication restrictions are in place

Restriction type: OTHER