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

NCT07047638 | Active Not Recruiting

• 1 other identifier: 43CH2308
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief 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

Skin Quality Improvement

Outcome Measures

Primary Outcomes (1)

• Responder rate based on the Blinded Evaluators' live assessment using the Galderma Skin Quality - Fine Lines Scale (GSQ-FLS).

  A responder is defined as a subject with at least 1-grade improvement from Baseline in both sides of the face concurrently on the scale. GSQ-FLS is a 5-grade scale with a higher score meaning a worse situation in fine line.

  At Week 12 after Baseline

Secondary Outcomes (1)

• Responder rate based on the Blinded Evaluators' live assessment using the GSQ-FLS

  At Week 16, 20, 24, 36, 48 and 60 after Baseline for the Treatment Group or at Week 16, 20 and 24 after Baseline for the no-treatment Control Group. GSQ-FLS is a 5-grade scale with a higher score meaning a worse situation in fine line.

Study Arms (2)

Restylane Skinboosters Vital Lidocaine

EXPERIMENTAL

Subjects in the Treatment Group will be treated with Restylane Skinboosters Vital Lidocaine at Baseline, Week 4 and 8.

Device: Restylane Skinboosters Vital Lidocaine

No treatment

NO INTERVENTION

No treatment control group.

Interventions

Restylane Skinboosters Vital Lidocaine DEVICE

Restylane 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.

Restylane Skinboosters Vital Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Acceptable forms of effective birth control include:
• Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical caps) with spermicidal foam/gel/film/cream/suppository;
• Bilateral tubal ligation;
• Combined oral contraceptives (estrogens and progesterone), implanted or injectable contraceptives on a stable dose for at least 28 days prior to Day 1;
• Hormonal or copper intra uterine device (IUD) inserted at least 28 days prior to Day 1;
• Vasectomized partner (in monogamous relationship) for at least 3 months prior to screening;
• Strict abstinence (at least one month prior to Baseline and agrees to continue for the duration of the study or use acceptable form of birth control).
• Negative pregnancy test for women of childbearing potential at the screening and Baseline visits.

You may not qualify if:

• 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:
• Previous permanent filler or implant, lifting threads, or autologous fat in the face regardless of time.
• Previous use of calcium hydroxylapatite (CaHA), polycaprolactone or poly-L-lactic acid (PLLA) in the treatment area within 24 months.
• Previous HA filler or collagen filler in the treatment area within 12 months.
• Previous botulinum toxin treatment in the treatment area within 6 months.
• Previous energy based aesthetic procedures (e.g., laser, intense pulsed light, radiofrequency, photomodulation and ultrasound) in the treatment area within 6 months.
• Previous mechanical (e.g., dermabrasion, needling) or chemical aesthetic procedures (e.g., chemical peel) in the treatment area within 6 months.
• Previous treatment with cryotherapy in the treatment area within 6 months.
• 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.:

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blind evaluator to assess study primary endpoint.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CN (1)