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
Verified date | August 2019 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04892407 -
Algeness DF 3.5% Compared to Voluma in Volume Deficit in Mid-face
|
N/A | |
Completed |
NCT01559064 -
The Volumizing Effect of Juvéderm VOLUMA® in the Mid-Face
|
N/A |