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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02980783 |
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Date of registration:
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30/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions
BEAM |
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Scientific title:
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BEAM: Prospective Open Label Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Treatment of Dynamic Radial Cheek Line Skin Depressions |
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Date of first enrolment:
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October 13, 2016 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02980783 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Graeme Kerson |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cheek Line Depressions
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Intervention(s)
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Device: Juvéderm® VOLIFT®™ with Lidocaine
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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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]
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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]
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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]
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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]
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Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile
[Time Frame: Baseline (Day 1) to Day 45]
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Secondary ID(s)
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GMA-EAME-FAS-0397
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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