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Active Not RecruitingNCT07047638

A Study to Evaluate the Effectiveness and Safety of Restylane Skinboosters Vital Lidocaine

A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Restylane Skinboosters Vital Lidocaine for Improvement in Skin Quality of the Face

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
171 (estimated)
Sponsor
Galderma R&D · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This is a randomized, evaluator-blinded, no-treatment controlled, study to evaluate the effectiveness and safety of Restylane Skinboosters Vital Lidocaine treatment to improve skin quality of the face in China. Subjects of Chinese origin, age 18 years, who are eligible for treatment to improve skin quality of the face. Study center is up to 8. A total of approximately 171 subjects will be randomized (2:1) to either treatment with Restylane Skinboosters Vital Lidocaine Treatment Group (approximately 114 subjects) or no-treatment Control Group (approximately 57 subjects).

Conditions

Interventions

TypeNameDescription
DEVICERestylane Skinboosters Vital LidocaineRestylane Skinboosters Vital Lidocaine is an injectable, sterile, transparent, biodegradable gel of non-animal crosslinked sodium hyaluronate. Restylane Skinboosters Vital Lidocaine has the addition of lidocaine hydrochloride. They are supplied in a glass syringe.

Timeline

Start date
2025-07-09
Primary completion
2026-05-31
Completion
2027-07-31
First posted
2025-07-02
Last updated
2026-03-12

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07047638. Inclusion in this directory is not an endorsement.