Status:
COMPLETED
Restylane Defyne in a Stepwise Treatment Approach
Lead Sponsor:
Galderma R&D
Conditions:
Lower Face Folds and Lines
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.
Eligibility Criteria
Inclusion
- Subjects willed to comply with the requirements of the study and provided a signed written informed consent
- Subjects willed to undergo augmentation and correction therapy in the studied indications
- Adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21
Exclusion
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
- Previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim
- Participation in any interventional clinical study within 30 days of screening
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04520997
Start Date
December 7 2020
End Date
September 15 2021
Last Update
April 14 2023
Active Locations (5)
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1
Galderma Research Site
Birmingham, Alabama, United States, 35209
2
Galderma Research Site
Chicago, Illinois, United States, 60611
3
Galderma Research Site
Belo Horizonte, Brazil
4
Galderma Research Site
São Paulo, Brazil