JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness

Allergan

Status: Completed

Conditions: Skin Smoothness of the Cheeks

Treatments: Device: JUVÉDERM VOLITE™ XC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03728309

1867-701-008

Details and patient eligibility

About

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.

Enrollment: 209 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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209 participants in 2 patient groups

JUVÉDERM® VOLITE™

Experimental group

Description:

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.

Treatment:

Device: JUVÉDERM VOLITE™ XC

Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™

Experimental group

Description:

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.

Treatment:

Device: JUVÉDERM VOLITE™ XC