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Skin Quality ImprovementNCT07047638

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

A study testing Restylane Skinboosters Vital Lidocaine in people with Skin Quality Improvement, run by Galderma R&D at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Skin Quality Improvement
What is being tested?
Restylane Skinboosters Vital Lidocaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
1 siteChina
Study dates
9 Jul 2025to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.:
  • Inflammation, active or chronic infection (e.g., in mouth, dentals, head, eye);
  • Current cutaneous inflammatory or infectious processes near or on the area to be treated (e.g., acne, dermatitis, herpes) which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessments;
  • Scars (other than from acne) or deformities;
  • Cancer, or precancerous conditions (e.g., actinic keratosis or actinic cheilitis).
  • Evidence of scar-related disease or delayed healing activity within 1 year prior to the Baseline visit, or subjects susceptible to keloid formation, hyperpigmentation or hypertrophic scarring in the opinion of the Investigator.
  • Presence of tattoo, piercing, beard or facial hair, which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment.
  • Presence of a dental, oral, or facial condition which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessments, e.g., has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities. Any planned procedure (e.g., dental implants, tooth extractions, orthodontia) during the study period, that would make the subject unsuitable for inclusion in the opinion of the Investigator.
  • An underlying known disease, a surgical or medical condition that would expose the subject to undue risk, e.g., history of bleeding disorders, active hepatitis, active autoimmune disease such as connective tissue diseases, systemic lupus erythematosus, polymyositis, dermatomyositis, or scleroderma.
  • Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation (e.g., warfarin, clopidogrel, aspirin or other non-steroidal anti-inflammatory drugs [NSAIDs], Omega-3 or Vitamin E), within 14 days prior to injection. Omega-3 and Vitamin E are acceptable only as part of a standard multivitamin formulation. Cyclooxygenase-2 (COX 2) inhibitors are allowed.
  • Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (eyedrops, intraarticular, and inhaled corticosteroids are allowed).
  • Use of topical corticosteroids or prescription retinoids on the treatment area within 1 months prior to Baseline or use of systemic retinoids within 6 months prior to Baseline.
  • Presence of any condition or situation, which in the opinion of the Treating Investigator makes the subject unable to complete the study per protocol, e.g.
  • Subject is not likely to avoid other prohibited facial cosmetic treatments;
  • Subject is not likely to complete the study because of other commitments;
  • Subject is anticipated to be unavailable for visits, incapable of understanding the investigational assessments or having unrealistic expectations of treatment result;
  • Subject who has a concomitant condition (e.g., acute viral or bacterial infection with fever) that might confuse or confound study treatments or assessments.
  • Study center personnel, close relatives of the study center personnel (e.g., parents, children, siblings, or spouse), employees or close relatives of employees at the Sponsor company.
  • Participation in any other interventional clinical study within 30 days before treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: 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

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).

Being tested
Restylane Skinboosters Vital Lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Restylane Skinboosters Vital LidocaineDevice

    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.

Study groups in NCT07047638
Study groupRoleWhat they receive
Restylane Skinboosters Vital LidocaineExperimentalSubjects in the Treatment Group will be treated with Restylane Skinboosters Vital Lidocaine at Baseline, Week 4 and 8.
Receives: Device: Restylane Skinboosters Vital Lidocaine
No treatmentNo interventionNo treatment control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Week 12 after Baseline

Secondary outcomes (1)

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2025
  2. Study start9 Jul 2025
  3. Primary completion28 Apr 2026
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
171 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07047638
Sponsor's protocol ID
43CH2308
Status last verified
Jun 2026
First submitted
24 Jun 2025
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Restylane Skinboosters Vital Lidocaine in people with Skin Quality Improvement, run by Galderma R&D at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder rate based on the Blinded Evaluators' live assessment using the Galderma Skin Quality - Fine Lines Scale (GSQ-FLS). (time frame: At Week 12 after Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07047638.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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