RecruitingInterventionalNot ApplicableUpdated Aug 14, 2026
Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation | NCT02703948 | Trialant
CompletedInterventionalNot ApplicableUpdated Aug 26, 2022
Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation
ClinicalTrials.gov ID
NCT02703948
Lead Sponsor
Galderma R&DINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
60Actual
Last Update Posted
Aug 26, 2022Actual
Start Date
Mar 2016
Primary Completion Date
Aug 2016Actual
Completion Date
Aug 2016Actual
Brief Summary
This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .
Lip Augmentation and Correction of Perioral Rhytids
Restylane Silk with Lidocaine
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
Subjects willing to comply with the requirements of the study and providing written informed consent including release of copyright of photography images.
Males or females, 22 years of age or older
Subjects seeking augmentation therapy for the lips.
Exclusion Criteria:
History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
History of allergy or hypersensitivity to lidocaine, other amide type anesthetics, or topical anesthetics or nerve blocking agents
Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.