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OpenTrials
Completed

NCT Number: NCT02980783

A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions

This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic radial cheek line skin depressions.

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Key information

Conditions

Cheek Line Depressions

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Laboratoire DERMSCAN

Lyon, 69100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Juvéderm® VOLIFT®™ with Lidocaine

Device

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 outcomes

  1. 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)

    Time frame: Baseline (Day 1) to Day 45

    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 outcomes

  1. Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®

    Time frame: Baseline (Day 1) to Day 45

    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.

  2. Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®

    Time frame: Baseline (Day 1) to Day 45

    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.

  3. Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®

    Time frame: Baseline (Day 1) to Day 45

    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.

  4. Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile

    Time frame: Baseline (Day 1) to Day 45

  5. Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS

    Time frame: Baseline (Day 1) to Day 45

    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.

  6. Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire

    Time frame: Baseline (Day 1) to Day 45

    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.

  7. Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire

    Time frame: Day 45

    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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

BEAM: Prospective Open Label Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Treatment of Dynamic Radial Cheek Line Skin Depressions

Acronym: BEAM

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2016
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.