Clinical trial NCT06372782: Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand
Official title: A Randomized, Split-Hand, Subject-Blinded Study Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital Without Lidocaine for Improved Appearance of the Dorsal Hand in Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging of Dorsal Hands
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: The within-subject difference in VAS score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at end of injection (T0).
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Galderma Research Site 01
state: Shanghai
city: Hangzhou
country: China
facility: Galderma Research Site 02
state: Zhejiang
city: Hangzhou
country: China
facility: Galderma Research Site 03
state: Zhejiang
Study officials:
affiliation: Galderma R&D
name: Galderma R&D
role: STUDY_DIRECTOR
References: