Pain and Safety of Restylane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds
NCT ID: NCT02918721
Last Updated: 2023-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2017-02-08
2017-05-11
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
DOUBLE
Study Groups
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Restylane Lidocaine
Restylane Lidocaine will be injected into one side nasolabial fold on Day 1
Restylane Lidocaine
Intradermal injection
Restylane
Restylane will be injected into the opposite side nasolabial fold on Day 1
Restylane
Intradermal injection
Interventions
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Restylane Lidocaine
Intradermal injection
Restylane
Intradermal injection
Eligibility Criteria
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Inclusion Criteria
* Men or women aged 18 years or older of Chinese origin
* 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
* Intent to undergo correction of both nasolabial folds(NLF) with a wrinkle severity in Wrinkle Severity Rating Scale(WSRS) of either 3 on both sides or 4 on both sides
Exclusion Criteria
* Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment
* Previous tissue revitalisation treatment with laser or light, mesotherapy radiofrequency, chemical peeling or dermabrasion in the midface within 6 months before treatment
* Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated
* 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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43CH1504
Identifier Type: -
Identifier Source: org_study_id
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