A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

Not Applicable

Completed

• Conditions: Age-related Volume Deficit in the Mid-face
• Interventions: Device: JUVÉDERM VOLUMA® XC injectable gel with cannula; Device: JUVÉDERM VOLUMA® XC injectable gel with needle

• Registration Number: NCT03438266
• Lead Sponsor: Allergan

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-05
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-19
• Primary Completion: 2018-05-29
• Study Completion: 2018-08-02
• Results First Submitted: 2019-05-29
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-01
• Last Update Submitted: 2019-08-01
• Results First Posted: 2019-08-05
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Male or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS);

Exclusion criteria:

• Has any facial procedures or trauma that may interfere with the study procedures and results;
• Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study;
• Has active autoimmune disease;
• Has current cutaneous or mucosal inflammatory or infectious processes.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JUVÉDERM VOLUMA® XC Injectable Gel with Cannula	JUVÉDERM VOLUMA® XC injectable gel with cannula	Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.
JUVÉDERM VOLUMA® XC Injectable Gel with Needle	JUVÉDERM VOLUMA® XC injectable gel with needle	Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score	Baseline (Screening) to Month 1	The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. A negative change from Baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score	Baseline (Screening) to Month 1	The EI assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. The percentage of participants who showed ≥1-point improvement (decrease in severity) from Baseline is reported.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Up to 3 months	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that initially occurred or increased in severity on or after the treatment start date.
Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score	Baseline (Screening) to Month 1	The participant completed the 5-item Satisfaction with Cheeks module of the FACE-Q questionnaire that evaluated various aspects of the cheeks including symmetry, smoothness, attractiveness, contour, and fullness using a 4-point scale where: 1=very dissatisfied to 4=very satisfied. The total score was transformed to a 0 to 100 point scale, with higher scores indicating greater satisfaction. A positive change from Baseline indicates improvement. The FACE-Q Satisfaction with Cheeks outcome was assessed by the participant overall and not by each cheek.

Trial Locations

Locations (7)

Art of Skin MD; 🇺🇸 Solana Beach, California, United States

Baumann Cosmetic and Research Institute; 🇺🇸 Miami, Florida, United States

Rhoda S. Narins, MD, PC; 🇺🇸 White Plains, New York, United States

Saint Louis University Dermatology; 🇺🇸 Saint Louis, Missouri, United States

Skin Care and Laser Physicians of Beverly Hills; 🇺🇸 Los Angeles, California, United States

Skin Laser & Surgery Specialists of NY/NJ; 🇺🇸 Hackensack, New Jersey, United States

Aesthetic Solutions, PA; 🇺🇸 Chapel Hill, North Carolina, United States