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

NCT ID: NCT01579305

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-01-31

Brief Summary

The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®

Conditions

Lip Volume Enhancement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Juvéderm® Volbella with Lidocaine

Subjects injected with Juvéderm® Volbella with Lidocaine in their lips

Group Type: EXPERIMENTAL

Juvéderm® Volbella with Lidocaine

Intervention Type: DEVICE

Up to 4.0 mL at the discretion of the Investigator to achieve optimal results

Restylane-L®

Subjects injected with Restylane-L® in their lips

Group Type: ACTIVE_COMPARATOR

Restylane-L®

Intervention Type: DEVICE

Up to 4.0 mL at the discretion of the Investigator to achieve optimal results

Interventions

Juvéderm® Volbella with Lidocaine

Up to 4.0 mL at the discretion of the Investigator to achieve optimal results

Intervention Type: DEVICE

Restylane-L®

Up to 4.0 mL at the discretion of the Investigator to achieve optimal results

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Desire enhancement of his/her vermilion borders and/or vermilion mucosa

2. Have a baseline score of Minimal or Mild, as assessed by the Investigator, according to the 5-point LFS (Minimal, Mild, Moderate, Marked, Very Marked)

3. Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable

Exclusion Criteria

1. Have undergone cosmetic facial, lip or perioral procedures [e.g., face-lift, or other surgeries, which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face or neck, or Botox® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry

2. Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cannes, , France

Glasgow, , United Kingdom

Countries

France; United Kingdom

References

Raspaldo H, Chantrey J, Belhaouari L, Saleh R, Murphy DK. Juvederm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. Plast Reconstr Surg Glob Open. 2015 Apr 7;3(3):e321. doi: 10.1097/GOX.0000000000000266. eCollection 2015 Mar.

Reference Type: BACKGROUND

PMID: 25878932 (View on PubMed)

Other Identifiers

S15L-003

Identifier Type: -

Identifier Source: org_study_id