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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT01579305
First received: April 16, 2012
Last updated: October 6, 2014
Last verified: August 2014

April 16, 2012
October 6, 2014
April 2012
June 2013   (final data collection date for primary outcome measure)
Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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).
Independent Central Reviewer assessment of lip fullness using the Lip Fullness Scale based on 3D photographic images [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01579305 on ClinicalTrials.gov Archive Site
Not Provided
  • Subject responses on the Recovery Early Life Impact scale of the FACE-Q questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Subject responses on the Recovery Early Symptoms scale of the FACE-Q questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Change in objective measurements of lip volume from baseline to 3 months follow last study treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement
Not Provided

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Lip Volume Enhancement
  • Device: Juvéderm® Volbella with Lidocaine
    Up to 4.0 mL at the discretion of the Investigator to achieve optimal results
  • Device: Restylane-L®
    Up to 4.0 mL at the discretion of the Investigator to achieve optimal results
  • Experimental: Juvéderm® Volbella with Lidocaine
    Subjects injected with Juvéderm® Volbella with Lidocaine in their lips
    Intervention: Device: Juvéderm® Volbella with Lidocaine
  • Active Comparator: Restylane-L®
    Subjects injected with Restylane-L® in their lips
    Intervention: Device: Restylane-L®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
285
January 2014
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France,   United Kingdom
 
NCT01579305
S15L-003
Not Provided
Allergan ( Allergan Medical )
Allergan Medical
Not Provided
Not Provided
Allergan
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP