Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547125
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM VOLITE Gel Filler in Adult Participants in China For the Improvement of Skin Quality
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Evaluator-Blinded Randomized No-Treatment Controlled Study of the Effectiveness and Safety of JUVÉDERM VOLITE Injectable Gel for the Improvement in Skin Quality in Chinese Adults
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Facial fine lines and wrinkles are caused by skin thinning loss of moisture and loss of elasticity due to factors such as age ultraviolet UV radiation and environmental exposures Today many injectable fillers are used to treat facial aging and correct skin defects In this study adverse effects and effectiveness of JUVÉDERM VOLITE will be assessed in the treatment of fine lines and improving skin quality
VOLITE is an investigational device being developed for improving skin quality In this study participants are placed in 1 of 2 groups called treatment arms Each group receives a different treatment There is a 1 in 3 chance that participants will be assigned to the no-treatment control group Adult participants seeking improvement of skin quality especially hydration and radiance in the treatment area will be enrolled Around 102 participants will be enrolled in the study at approximately 8 sites in China
Participants in the treatment group will receive the initial injection of VOLITE the control group will receive no treatment but will have the opportunity to receive VOLITE after 2 months Participants will be followed up for 12 months
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments checking for side effects and completing questionnaires
VOLITE is an investigational device being developed for improving skin quality In this study participants are placed in 1 of 2 groups called treatment arms Each group receives a different treatment There is a 1 in 3 chance that participants will be assigned to the no-treatment control group Adult participants seeking improvement of skin quality especially hydration and radiance in the treatment area will be enrolled Around 102 participants will be enrolled in the study at approximately 8 sites in China
Participants in the treatment group will receive the initial injection of VOLITE the control group will receive no treatment but will have the opportunity to receive VOLITE after 2 months Participants will be followed up for 12 months
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments checking for side effects and completing questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None