Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds

NCT01680497 | Completed Results

• 1 other identifier: MAF/AGN/MED/FIL/018
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 3

Brief Summary

A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds

Conditions

Moderate to Severe Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)

  Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).

  Month 12

Secondary Outcomes (6)

• Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS

  Day 0, Day 14, Month 1, Month 9

• Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale

  Day 14, Month 1, Month 9, Month 12

• Investigator Assessment of Ease of Injection Use on a 10-Point Scale

  Day 0, Day 14

• Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS

  Day 0, Day 14, Month 1, Month 9, Month 12

• Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale

  Day 14, Month 1, Month 9, Month 12

Study Arms (1)

JUVÉDERM VOLIFT™

EXPERIMENTAL

All subjects receiving treatment with JUVÉDERM VOLIFT™.

Device: Crosslinked hyaluronic acid dermal filler

Interventions

Crosslinked hyaluronic acid dermal filler DEVICE

All treatment details are at the discretion of the Investigator and should be guided by the Directions for Use. Up to 3 treatments will be administered: Initial treatment, optional top-up treatment at Day 14 post-initial treatment, and optional repeat treatment at Month 12 post-initial treatment.

Also known as: JUVÉDERM VOLIFT™

JUVÉDERM VOLIFT™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 years of age or older
• Have 2 fully visible, approximately symmetrical nasolabial folds and has severity scores of 2 or 3 on the 5-point photographic nasolabial fold severity scale (range 0-4) for both nasolabial folds, as judged by the Investigator
• Have a reasonable expectation for correction by injection via deep dermis, as described in the protocol
• Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face (below the orbital rim) for the duration of the study
• Understand and be willing to follow all aspects of the study protocol and have signed and dated the Informed Consent prior to any study-related procedures being performed
• Be in good health as in the opinion of the Investigator

You may not qualify if:

• Has undergone cosmetic facial procedures (e.g., face lift or other surgeries) which may alter the appearance of the nasolabial fold area
• Cosmetic injections in the lower two-thirds of the 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
• Has undergone volumizing of the mid/lower face within 9 months prior to study entry
• Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded poly-tetrafluoroethylene) anywhere in the lower face (below the orbital rim), or be planning to be implanted with any of these products at any time during the study
• Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine (an any amide-based anesthetics), HA products, or Streptococcal protein, or be planning to undergo a desensitization therapy during the term of the study
• Be a pregnant female, lactating, or planning to become pregnant at any time during the study
• Be a female of childbearing potential not using a reliable means of contraception
• Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
• Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression)
• Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease)
• Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or without heart complications)
• Have a history of skin cancer
• Suffer from porphyria
• Have epilepsy, which is not controlled by anti-epilepsy therapy
• Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes)

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Darmstadt, Germany

Location

Unknown Facility

Naarden, Netherlands

Location

Related Publications (1)

• Sattler G, Philipp-Dormston WG, Van Den Elzen H, Van Der Walt C, Nathan M, Kolodziejczyk J, Kerson G, Dhillon B. A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months. Dermatol Surg. 2017 Feb;43(2):238-245. doi: 10.1097/DSS.0000000000000939.

  PMID: 28165349 BACKGROUND

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Monitor

  Allergan Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 7, 2012
• Study Start: June 1, 2012
• Primary Completion: March 6, 2014
• Study Completion: March 6, 2014
• Last Updated: April 16, 2019
• Results First Posted: June 23, 2015

Record last verified: 2019-04

Locations

DE (2); NL (1)