Restylane
DeviceFacial tissue augmentation
NCT Number: NCT02565784
The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population.
Looking for future studies?
Notify Me25 year–50 year
Female
Interventional
Not applicable
Galderma Research Site, Kaohsiung City, Taiwan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Facial tissue augmentation
Facial tissue augmentation
Time frame: 6 Months
Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment.
The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse.
A participant is considered "improved" if she answers Very much improved, Much improved, or Improved.
Time frame: 6 and 12 Months after first and second treatment, respectively
The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is "No folds" and 4 is "Very severe folds".
A participant is considered improved if she scores at least one grade improvement from baseline.
Time frame: 6 and 12 Months after first and second treatment, respectively
The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is "Full upper cheek" and 4 is "Very severely sunken upper cheek".
A participant is assessed as improved if she scores at least one grade improvement from baseline.
Galderma R&D
Industry
An Open, Evaluator-blinded, Non-comparative, Multi-center Study to Assess the Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population
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.
Published trials that share one or more normalized conditions with this study.
NCT00862433
Body Weight, Diabetes
Bethesda, Maryland, United States
View Trial DetailsNCT07422298
Healthy Volunteers
San Antonio, Texas, United States
View Trial DetailsNCT07215299
Healthy Volunteers
Bloomington, Indiana, United States
View Trial DetailsNCT03113903
Anxiety Disorders, Behavior
Clermont-Ferrand, France
View Trial Details