Actively Recruiting
A Randomized, Evaluator-blinded Study to Evaluate the Effectiveness and Safety of Restylane Skinboosters Vital Lidocaine for Improving Skin Quality of the Face
Led by Galderma R&D · Updated on 2026-05-22
171
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Restylane Skinboosters Vital Lidocaine treatment to improve skin quality of the face in adults of Chinese origin aged 18 years and older. This randomized, evaluator-blinded study compares the treatment against a no-treatment control group and aims to assess improvements in fine lines, skin dryness, and skin radiance. Participants in the treatment group will receive injections of Restylane Skinboosters Vital Lidocaine at baseline, week 4, and week 8. The control group will not receive any treatment. Restylane Skinboosters Vital Lidocaine is a sterile, biodegradable gel containing sodium hyaluronate and lidocaine hydrochloride, supplied in a glass syringe. The study includes multiple centers and approximately 171 subjects randomized in a 2:1 ratio to treatment or control. During the study, participants will be assessed by blinded evaluators at week 12 and at several later time points up to week 60 for the treatment group and up to week 24 for the control group using the Galderma Skin Quality - Fine Lines Scale. Assessments include live evaluations of skin quality focusing on fine lines. Participants will undergo regular visits and evaluations to monitor safety and treatment effects throughout the study duration.
CONDITIONS
Brief Title
A Study to Evaluate the Effectiveness and Safety of Restylane Skinboosters Vital Lidocaine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand study information and give written consent
- Male or non-pregnant, non-breastfeeding female of Chinese origin aged 18 years or older
- Moderate to severe fine lines (grade 3 to 4 on GSQ-FLS) on each side of the face
- Willing to avoid other facial cosmetic or surgical procedures during the study
- Intends to improve skin quality including fine lines, dryness, and radiance
- For females of childbearing potential: agrees to use effective birth control and take pregnancy tests as required
- Negative pregnancy test at screening and baseline for females of childbearing potential
You will not qualify if you...
- Allergy or sensitivity to hyaluronic acid gels or gram positive bacterial proteins
- Allergy to anesthetics like lidocaine or nerve blockers
- History of severe allergies such as anaphylaxis or angioedema
- Previous facial surgery that may affect safety or assessments
- Previous aesthetic procedures or implants in the face including permanent fillers, lifting threads, fat grafts, or certain fillers within specified time frames
- History of cancer or radiation in the treatment area
- Advanced photoaged or fragile facial skin
- Active or chronic infections or inflammatory skin conditions near the treatment area
- Scars or deformities other than acne scars
- Skin cancer or precancerous conditions in the treatment area
- Scar-related disease or delayed healing tendencies
- Tattoos, piercings, beard or facial hair interfering with assessments
- Dental or facial conditions that may interfere with injections or assessments
- Underlying diseases or conditions posing undue risk such as bleeding disorders or autoimmune diseases
- Use of medications that affect bleeding within 14 days prior to injection
- Recent chemotherapy, immunosuppressants, or systemic corticosteroids
- Use of topical or systemic retinoids near the treatment area within specified time frames
- Conditions or situations that may prevent study completion or compliance
- Study personnel or close relatives involved with the study center or sponsor
- Participation in another interventional study within 30 days before treatment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive Restylane Skinboosters Vital Lidocaine injections at Baseline, Week 4, and Week 8 to improve skin quality of the face.
3 visits (in-person)
Duration - Up to 52 weeks after treatment
Participants are assessed for treatment effectiveness and safety at several timepoints after the last treatment.
6 visits (in-person) for the Treatment Group; 3 visits (in-person) for the No Treatment Group
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
N
Nicole Gladerma Research & Development
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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