Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
209 participants
INTERVENTIONAL
2018-11-09
2020-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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JUVÉDERM® VOLITE™
Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 milliliters (mL) on Day 1 followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4 mL at Month 6, if applicable.
JUVÉDERM VOLITE™ XC
Intradermal, needle in multiple microdepot injections across both cheeks.
Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™
Participants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable.
JUVÉDERM VOLITE™ XC
Intradermal, needle in multiple microdepot injections across both cheeks.
Interventions
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JUVÉDERM VOLITE™ XC
Intradermal, needle in multiple microdepot injections across both cheeks.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent and data privacy consent have been obtained
Exclusion Criteria
* Has received any crosslinked HA filler in any anatomic area within 12 months of screening;
* Has undergone treatment with botulinum toxin in the cheek area (including crow's feet) within 6 months of screening or is planning to undergo such treatment during the study;
* Has ever received semi-permanent fillers or permanent facial implants (eg, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafuoroethylene) anywhere in the face or is planning to be implanted with any of these products at any time during the study;
* Has facial tattoos, piercings, pigmentation, hair (ie, beard, mustache), or past trauma that would interfere with the visualization of the face for the effectiveness assessments;
* Has undergone a dental procedure within 6 weeks before treatment or plans to undergo a dental procedure (other than prophylasix or dental fillings) during the course of the study;
* Has tendency to develop hypertrophic scarring;
* Has a history of allergy to lidocaine, HA products, and/or to gram-positive bacterial proteins as HA is produced by Streptococcus-type bacteria, or is planning to undergo desensitization therapy during the term of the study;
* Has a history of anaphylactic shock;
* Has current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face (injection may be delayed to allow subjects with a history of recurrent oral herpes to take prophylactic antiviral/herpes medication for 2 days);
* Is on an ongoing regimen of anticoagulation therapy (eg, warfarin) or is known to have a coagulation disorder;
* Is on an ongoing regimen of medications (eg, aspirin, ibuprofen) or other substances (eg, herbal supplements with garlic, ginkgo biloba, or ginseng) known to increase coagulation time within 10 days of undergoing study device injection (study device injection may be delayed as necessary to accommodate this 10-day washout period);
* Has active autoimmune disease;
* Has received any investigational product within 30 days before enrollment or is planning to participate in another investigation during the course of this study; - Has begun using any over-the-counter or prescription, oral or topical, anti-wrinkle products on the face within 30 days before enrollment or is planning to begin using such products during the study (subjects who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study);
* Females who are pregnant, nursing, or planning a pregnancy during the study;
* Is an employee (or a relative of an employee) of the principal investigator (PI)/evaluating investigator (EI)/treating investigator(TI)/site, Allergan, or representative of Allergan'
* Has a condition or is in a situation which, in the TI's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
22 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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ALLERGAN, INC.
Role: STUDY_DIRECTOR
Allergan
Locations
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Kathleen L. Behr M.D. Inc /ID# 236170
Fresno, California, United States
Dermatology Research Associates /ID# 237649
Los Angeles, California, United States
Ava MD
Santa Monica, California, United States
Art of Skin MD
Solana Beach, California, United States
Skin Research Institute LLC
Coral Gables, Florida, United States
Advanced Dermatology /ID# 234879
Lincolnshire, Illinois, United States
Facial Plastic Surgery Center /ID# 234876
Baltimore, Maryland, United States
Skincare Physicians /ID# 235383
Chestnut Hill, Massachusetts, United States
Dermatology PartnersInc. /ID# 234946
Wellesley, Massachusetts, United States
Dermatology and Laser Surgery Center of New York /ID# 234571
New York, New York, United States
Dermatology Laser and Vein Specialists of Carolinas /ID# 236169
Charlotte, North Carolina, United States
Clinical Research Center of the Carolinas /ID# 236488
Charleston, South Carolina, United States
Dallas Center for Dermatology and Aesthetics /ID# 234452
Dallas, Texas, United States
Jose Raul Montes Eyes & Facial Rejuvenation
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1867-701-008
Identifier Type: -
Identifier Source: org_study_id