Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand

NCT06372782 | Completed Results

• 1 other identifier: 43CH2305
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal hands in Chinese subjects.

Conditions

Skin Aging of Dorsal Hands

Outcome Measures

Primary Outcomes (1)

• The Within-subject Difference in VAS Score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at End of Injection (T0).

  The VAS is a subjective scale to measure pain intensity. Total range is 0-100, 0 represents no pain and 100 represents the worst pain you can imagine, meaning a lower value is considered a better outcome in terms of a less painful treatment. The subject shall be instructed to put a vertical mark, approximating the pain experienced after the procedure, on a 100 mm horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the subject's VAS mark shall be measured with a standard ruler. Each hand will be evaluated independently.

  End of Injection (T0)

Study Arms (2)

Restylane Skinboosters Vital Lidocaine

EXPERIMENTAL

Participant's one hand treated by Restylane Skinboosters Vital Lidocaine

Device: Restylane Skinboosters Vital Lidocaine

Restylane Vital

ACTIVE COMPARATOR

Participant's another hand treated by Restylane Vital

Device: Restylane Vital

Interventions

Restylane Skinboosters Vital Lidocaine DEVICE

Each subject will receive treatment on Day 1 with Restylane Skinboosters Vital Lidocaine in one hand and Restylane Vital in the opposite hand, as randomly assigned.

Restylane Skinboosters Vital Lidocaine

Restylane Vital DEVICE

Each subject will receive treatment on Day 1 with Restylane Vital in one hand and the experimental device in the opposite hand, as randomly assigned

Restylane Vital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent to participate in the study
• Chinese origin
• Age at least 18 years
• The subject is willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions
• Subjects eligible for treatment to improve appearance of the dorsal hand by increasing tissue volume
• Same grade of tissue degeneration and need for treatment in both hands

You may not qualify if:

• Any previous non-permanent or permanent implant/filler in the hands, including autologous fat
• Any mesotherapy or resurfacing procedure (laser, chemical peels or other ablative or non-ablative treatment) in the hands within 6 months prior to baseline
• Any previous hand surgery including sclerotherapy
• Any fibrosis or scarring or deformities on the hands
• Advanced photoaged/ photodamaged skin (e.g. advanced skin elastosis, multiple lentigo solaris lesions) or skin condition with very crinkled or fragile skin on the dorsal hands
• Subjects with active skin disease, inflammation or related conditions in the hand
• Subjects with a history of precancerous (e.g. actinic keratosis) or cancerous lesions in the hands
• Subjects with a history of Raynaud´s disease or phenomenon, or history of other disease that may affect peripheral circulation
• History of neurological disease that may affect peripheral neurological function
• Subjects with a history of autoimmune disease or joint disease or connective tissue disease (e.g. rheumatoid arthritis, lupus, scleroderma etc)
• Subjects with known hypersensitivity to any ingredient of the study product or anesthesia used in the study or with a history of any significant Adverse Events caused by dermal fillers
• Use of topical retinoids on the dorsal hands within 6 weeks prior to baseline or use of systemic retinoids within 6 months prior to baseline
• History of chronic lymph edema or breast cancer /mastectomy with potential to cause edema
• Concomitant thrombolytic or anticoagulant therapy and therapy with inhibitors of platelet aggregation, (e.g. non-steriod anti-inflammatory drugs, acetylsalicylic acid, Omega 3 and Vitamin E) within 2 weeks prior to treatment, or a history of bleeding disorders. Cyclooxygenase-2 (COX-2) inhibitors are allowed
• Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (dorsal hands) corticosteroids (inhaled corticoids are allowed) within three months before study treatment

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Galderma Research Site 01

Shanghai, Shanghai Municipality, China

Location

Galderma Research Site 02

Hangzhou, Zhejiang, China

Location

Galderma Research Site 03

Hangzhou, Zhejiang, China

Location

Results Point of Contact

• Title: Clinical Scientist
• Organization: Q-Med AB

reception.seupp@galderma.com

+46184749000

Study Officials

• Galderma R&D

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each subject will receive treatment on Day 1 with Restylane Skinboosters Vital Lidocaine® in one hand and Restylane Vital in the opposite hand, as randomly assigned. Subject was kept bline is that he/she does not know which product treatment their hands received separately
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: April 24, 2024
• Primary Completion: June 28, 2024
• Study Completion: July 16, 2024
• Last Updated: October 10, 2025
• Results First Posted: October 10, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)