Restylane Volyme for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
NCT ID: NCT03289052
Last Updated: 2023-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
168 participants
INTERVENTIONAL
2017-12-01
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Restylane Volyme
Single injection and optional touch up injection with Restylane Volyme in Midface
Restylane Volyme
Subcutis injection
No intervention arm
No treatment
No interventions assigned to this group
Interventions
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Restylane Volyme
Subcutis injection
Eligibility Criteria
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Inclusion Criteria
2. Men or women aged 18 years of age or older of Chinese origin
3. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
4. Subjects seeking augmentation therapy for the midface
5. MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator
Exclusion Criteria
2. Previous surgery or tattoo in the area to be treated
3. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.
4. Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim or neurotoxin within 9 months before treatment.
5. Scars or deformities, active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne psoriasis and herpes zoster near or in the area to be treated.
6. Other condition preventing the subject from entering the study in the Investigator's opinion.
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Q-Med AB
Shanghai, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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43CH1626
Identifier Type: -
Identifier Source: org_study_id
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