Back to resultsA Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions (BEAM)
Primary Purpose
Cheek Line Depressions
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Juvéderm® VOLIFT®™ with Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Cheek Line Depressions
Eligibility Criteria
Inclusion Criteria:
- Presence of dynamic radial cheek lines
- Agrees not to make any changes to skin care routines, or to have any facial procedures or treatments during the study
Exclusion Criteria:
- Previous facial surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures during the study
- Undergone temporary facial dermal filler injections with any substance in the face in the 12 months prior to study entry
- Received botulinum toxin therapy of any serotype in any facial area within the previous 6 months agrees not to receive it during the study
Sites / Locations
- Laboratoire DERMSCAN
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Juvéderm® VOLIFT®™ with Lidocaine
Arm Description
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
Outcomes
Primary Outcome Measures
Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)
Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.
Secondary Outcome Measures
Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers (μm). A negative change from Baseline (pre-treatment) indicates that the roughness of wrinkles decreased.
Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the texture of wrinkles improved.
Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the amplitude of wrinkles decreased.
Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile
Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS
The investigator graded the improvement of the participant's dynamic radial cheek lines on both sides of their face using the 5-point GAIS where -2=much worse to +2=much improved. Responders are participants with a score of +1 or +2 (improved or much improved, respectively) on both sides; partial responder are participants with a score of +1 or +2 on only one side; and no-responders are participants with a score lower or equal to 0 on both sides. The percentages of responders, partial responders, and no-responders are reported.
Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
The SPA questionnaire consists of one question: "How do you think your facial appearance looks compared to your age TODAY?" Participants could choose one of three possible answers: "I look my current age," "I look younger," or "I look older." The percentage of participants in the following SPA categories is reported: I look my current age, I look younger and I look older.
Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire
Participants were asked to indicate their level agreement with the following statement: "The treatment of my smile lines gave me a natural look." Responses were scored from 0 to 10, where 0=not at all to 10=very much.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02980783
Brief Title
A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions
Acronym
BEAM
Official Title
BEAM: Prospective Open Label Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Treatment of Dynamic Radial Cheek Line Skin Depressions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 13, 2016 (Actual)
Primary Completion Date
December 14, 2016 (Actual)
Study Completion Date
December 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic radial cheek line skin depressions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cheek Line Depressions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Juvéderm® VOLIFT®™ with Lidocaine
Arm Type
Experimental
Arm Description
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
Intervention Type
Device
Intervention Name(s)
Juvéderm® VOLIFT®™ with Lidocaine
Intervention Description
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine is injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine will be injected on Day 14; volume will not exceed 1 mL per side.
Primary Outcome Measure Information:
Title
Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)
Description
Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.
Time Frame
Baseline (Day 1) to Day 45
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
Description
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers (μm). A negative change from Baseline (pre-treatment) indicates that the roughness of wrinkles decreased.
Time Frame
Baseline (Day 1) to Day 45
Title
Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
Description
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the texture of wrinkles improved.
Time Frame
Baseline (Day 1) to Day 45
Title
Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
Description
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the amplitude of wrinkles decreased.
Time Frame
Baseline (Day 1) to Day 45
Title
Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile
Time Frame
Baseline (Day 1) to Day 45
Title
Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS
Description
The investigator graded the improvement of the participant's dynamic radial cheek lines on both sides of their face using the 5-point GAIS where -2=much worse to +2=much improved. Responders are participants with a score of +1 or +2 (improved or much improved, respectively) on both sides; partial responder are participants with a score of +1 or +2 on only one side; and no-responders are participants with a score lower or equal to 0 on both sides. The percentages of responders, partial responders, and no-responders are reported.
Time Frame
Baseline (Day 1) to Day 45
Title
Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
Description
The SPA questionnaire consists of one question: "How do you think your facial appearance looks compared to your age TODAY?" Participants could choose one of three possible answers: "I look my current age," "I look younger," or "I look older." The percentage of participants in the following SPA categories is reported: I look my current age, I look younger and I look older.
Time Frame
Baseline (Day 1) to Day 45
Title
Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire
Description
Participants were asked to indicate their level agreement with the following statement: "The treatment of my smile lines gave me a natural look." Responses were scored from 0 to 10, where 0=not at all to 10=very much.
Time Frame
Day 45
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of dynamic radial cheek lines
Agrees not to make any changes to skin care routines, or to have any facial procedures or treatments during the study
Exclusion Criteria:
Previous facial surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures during the study
Undergone temporary facial dermal filler injections with any substance in the face in the 12 months prior to study entry
Received botulinum toxin therapy of any serotype in any facial area within the previous 6 months agrees not to receive it during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graeme Kerson
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Laboratoire DERMSCAN
City
Lyon
ZIP/Postal Code
69100
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information
Learn more about this trial
A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions
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