A Study to Evaluate the Effectiveness and Safety of Restylane Skinboosters Vital Lidocaine (NCT07047638) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study to Evaluate the Effectiveness and Safety of Restylane Skinboosters Vital Lidocaine
China171 participantsStarted 2025-07-09
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study. Signed and dated informed consent to participate in the study.
✓. Males or non-pregnant, non-breastfeeding females of Chinese origin and 18 years of age or older at the time of signing the Informed Consent Form.
✓. Grade 3 (moderate) to 4 (severe) on the 5-grade GSQ-FLS on each side of the face as assessed by the Blinded Evaluator as well as the Treating Investigator (agreement on grade is not required). The GSQ-FLS grade for the right and the left side of the face does not have to be equal.
✓. Willing to abstain from any other facial plastic surgical or cosmetic procedures in the face for the duration of the study (e.g., Botulinum toxin, dermal filler, laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).
✓. Intent to undergo treatment for improvement in skin quality of the face including improvement in fine lines, skin dryness and skin radiance.
✓. If the subject is a female of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) at screening (or a serum HCG blood test if UPT is not available), Baseline and prior to receiving any study treatment.
What they're measuring
1
Responder rate based on the Blinded Evaluators' live assessment using the Galderma Skin Quality - Fine Lines Scale (GSQ-FLS).
. Negative pregnancy test for women of childbearing potential at the screening and Baseline visits.
Exclusion criteria
✕. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
✕. Known/previous allergy or hypersensitivity to anesthetics, e.g., lidocaine or other amide-type anesthetics or nerve blocking agents.
✕. Previous or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
✕. Previous facial surgery (e.g., facelift) that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments.
✕. Any previous aesthetic procedures or implants:
✕. History of cancer or previous radiation in the treatment area.
✕. Advanced photoaged/ photodamaged facial skin (e.g. advanced skin elastosis, multiple lentigo solaris lesions) or skin condition with very crinkled or fragile skin in the face.
✕. Presence of any disease or lesions near or on the area to be treated, e.g.: