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

Age-related Volume Deficit in the Mid-face Clinical Trial

Official title:

A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438266
• Other study ID #: 1650-801-008
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: August 2, 2018

Study information

• Verified date: August 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Volume Deficit in the Mid-face

Intervention

Device:
• 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
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.

Locations

Country	Name	City	State
United States	Aesthetic Solutions, PA	Chapel Hill	North Carolina
United States	Skin Laser & Surgery Specialists of NY/NJ	Hackensack	New Jersey
United States	Skin Care and Laser Physicians of Beverly Hills	Los Angeles	California
United States	Baumann Cosmetic and Research Institute	Miami	Florida
United States	Saint Louis University Dermatology	Saint Louis	Missouri
United States	Art of Skin MD	Solana Beach	California
United States	Rhoda S. Narins, MD, PC	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score	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.	Baseline (Screening) to Month 1
Secondary	Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score	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.	Baseline (Screening) to Month 1
Secondary	Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score	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.	Baseline (Screening) to Month 1
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	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.	Up to 3 months

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.