CompletedNot Applicable

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

France, United Kingdom285 participantsStarted 2012-04

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Desire enhancement of his/her vermilion borders and/or vermilion mucosa
✓. 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)
✓. Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable

✕. 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
✕. 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

Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment

Timeframe: 3 months

NCT IDNCT01579305

SponsorAllergan Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-06

Results submitted2014-06-27

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Desire enhancement of his/her vermilion borders and/or vermilion mucosa
✓. 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)
✓. Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable

✕. 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
✕. 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