CompletedNot Applicable

Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation

United States60 participantsStarted 2016-03

Plain-language 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 .

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine

Timeframe: 12 weeks

Trial details

NCT IDNCT02703948

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08

Results submitted2018-01-25

View on ClinicalTrials.gov More Lip Augmentation and Correction of Perioral Rhytids trials