Trials / Completed
CompletedNCT05009381
Effectiveness and Safety of STYLAGE® XXL for Chin Augmentation in Chinese Adults
A No-treatment Controlled, Prospective, Randomized, Multimulti-center, Evaluator-Blinded Study to Evaluate the Effectiveness and Safety of STYLAGE® XXL for Chin Augmentation in Chinese Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Laboratoires Vivacy · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The aim of this trial is to demonstrate the efficacy and safety of STYLAGE® XXL in augmenting the chin volume among Chinese adults. Subjects will be randomized either to the treatment group or the control group in a 4:1 ratio The superiority of STYLAGE® XXL against no-treatment control in chin volume augmentation will be verified together with assessments of the safety profiles.
Detailed description
This study is a no-treatment controlled, prospective, randomized, multi-center, evaluator-blinded study, in Chinese subjects seeking for chin volume augmentation. 150 subjects will be randomized either to the treatment group or the control group in a 4:1 ratio (120 subjects in the treatment group and 30 subjects in the control group). Subjets assigned to the treatment group will receive STYLAGE® XXL at enrollment. Subjects assigned to the control group will not receive treatment at enrollment; however, at 6 month visit, subjects who are still eligible for chin augmentation with STYLAGE® XXL will be treated STYLAGE® XXL superiority will be demonstrated against no-treatment control in augmenting the chin volume, as measured by blinded evaluator at 6-month
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Stylage XXL at enrollment | Injection in the chin at enrollment |
| DEVICE | Stylage XXL at Month 6 | Injection in the chin 6 months after randomization |
Timeline
- Start date
- 2021-09-10
- Primary completion
- 2022-10-26
- Completion
- 2023-08-31
- First posted
- 2021-08-17
- Last updated
- 2023-09-21
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05009381. Inclusion in this directory is not an endorsement.