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

Not Applicable

Completed

• Conditions: Skin Aging of Dorsal Hands
• Interventions: Device: Restylane Skinboosters Vital Lidocaine; Device: Restylane Vital

• Registration Number: NCT06372782
• Lead Sponsor: Galderma R&D

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-04-24
• Primary Completion: 2024-06-28
• Study Completion: 2024-07-16
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Signed and dated informed consent to participate in the study
2. Chinese origin
3. Age at least 18 years
4. 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
5. Subjects eligible for treatment to improve appearance of the dorsal hand by increasing tissue volume
6. Same grade of tissue degeneration and need for treatment in both hands

Exclusion Criteria

1. Any previous non-permanent or permanent implant/filler in the hands, including autologous fat
2. Any mesotherapy or resurfacing procedure (laser, chemical peels or other ablative or non-ablative treatment) in the hands within 6 months prior to baseline
3. Any previous hand surgery including sclerotherapy
4. Any fibrosis or scarring or deformities on the hands
5. 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
6. Subjects with active skin disease, inflammation or related conditions in the hand
7. Subjects with a history of precancerous (e.g. actinic keratosis) or cancerous lesions in the hands
8. Subjects with a history of Raynaud´s disease or phenomenon, or history of other disease that may affect peripheral circulation
9. History of neurological disease that may affect peripheral neurological function
10. Subjects with a history of autoimmune disease or joint disease or connective tissue disease (e.g. rheumatoid arthritis, lupus, scleroderma etc)
11. 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
12. 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
13. History of chronic lymph edema or breast cancer /mastectomy with potential to cause edema
14. 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
15. 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
16. History of untreated epilepsy or other significant medical conditions
17. Women who are pregnant or breast feeding, or Woman of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
18. Subjects participating in another interventional clinical study within 30 days of baseline
19. Subjects with unattainable expectation with regard to the aesthetic results of the treatment
20. Subjects who are involved in conducting the study (e.g. colleagues within the same department) or close relatives to any of the study staffs (e.g. parents, children, siblings or spouse ) as well as subjects who are employed by the Sponsor company, or close relatives of employees at the Sponsor company
21. Subjects with any other condition which in the opinion of the Investigator, might compromise the subject's ability to tolerate the injection procedure or comply with requirements of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restylane Skinboosters Vital Lidocaine	Restylane Vital	Subjects' hands treated by Restylane Skinboosters Vital Lidocaine
Restylane Vital	Restylane Skinboosters Vital Lidocaine	Subjects' hands treated by Restylane Vital
Restylane Skinboosters Vital Lidocaine	Restylane Skinboosters Vital Lidocaine	Subjects' hands treated by Restylane Skinboosters Vital Lidocaine
Restylane Vital	Restylane Vital	Subjects' hands treated by Restylane Vital

Primary Outcome Measures

Name	Time	Method
The within-subject difference in VAS score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at end of injection (T0).	Baseline	The VAS is a subjective scale to measure pain intensity. 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.

Trial Locations

Locations (3)

Galderma Research Site 01; 🇨🇳 Shanghai, Shanghai, China

Galderma Research Site 02; 🇨🇳 Hangzhou, Zhejiang, China

Galderma Research Site 03; 🇨🇳 Hangzhou, Zhejiang, China