Clinical trial NCT03728309: JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness
Official title: Protocol Title: A Randomized, Multicenter, Evaluator-blind, Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLITE™ XC Injectable Gel for the Improvement in Cheek Skin Smoothness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Smoothness of the Cheeks
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-11-02
Enrollment: 209
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pivotal study to collect safety and effectiveness data on JUVÉDERM VOLITE™ XC for improvement in skin smoothness of the cheeks in order to support FDA product approval.


Eligibility criteria: Inclusion Criteria:

* Ability to follow study instructions and likely to complete all required visits;
* Written informed consent and data privacy consent have been obtained

Exclusion Criteria:

* Has undergone tissue augmentation with dermal fillers including hyaluronic acid (HA), calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg, face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the fact within 12 months before screening or is planning to undergo any such treatment during the study;
* 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

Primary outcomes:
measure: Percentage of Participants With at Least 1-point Improvement (Decrease) From Baseline on the Allergan Cheek Smoothness Scale (ACSS) on Both Cheeks at Month 1
timeFrame: Baseline to Month 1
measure: Number of Participants Who Experience One or More Treatment Emergent Adverse Event (TEAE)
timeFrame: From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)
Secondary outcomes:
measure: Change From Baseline in Face-Q Satisfaction With Skin Questionnaire at Month 1
timeFrame: Baseline and Month 1
measure: Percentage of Participants With at Least 1-Point Improvement (Decreased) From Baseline on Both Cheeks in the Allergan Fine Lines Scale (AFLS) Response at Month 1
timeFrame: Baseline to Month 1
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Kathleen L. Behr M.D. Inc /ID# 236170
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates /ID# 237649
state: California
city: Santa Monica
country: United States
facility: Ava MD
state: California
city: Solana Beach
country: United States
facility: Art of Skin MD
state: California
city: Coral Gables
country: United States
facility: Skin Research Institute LLC
state: Florida
city: Lincolnshire
country: United States
facility: Advanced Dermatology /ID# 234879
state: Illinois
city: Baltimore
country: United States
facility: Facial Plastic Surgery Center /ID# 234876
state: Maryland
city: Chestnut Hill
country: United States
facility: Skincare Physicians /ID# 235383
state: Massachusetts
city: Wellesley
country: United States
facility: Dermatology PartnersInc. /ID# 234946
state: Massachusetts
city: New York
country: United States
facility: Dermatology and Laser Surgery Center of New York /ID# 234571
state: New York
city: Charlotte
country: United States
facility: Dermatology Laser and Vein Specialists of Carolinas /ID# 236169
state: North Carolina
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas /ID# 236488
state: South Carolina
city: Dallas
country: United States
facility: Dallas Center for Dermatology and Aesthetics /ID# 234452
state: Texas
city: San Juan
country: Puerto Rico
facility: Jose Raul Montes Eyes & Facial Rejuvenation
Study officials:
affiliation: Allergan
name: ALLERGAN, INC.
role: STUDY_DIRECTOR
References: