Effectiveness and Safety of STYLAGE® XXL for Chin Augmentation in Chinese Adults (NCT05009381) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness and Safety of STYLAGE® XXL for Chin Augmentation in Chinese Adults
China174 participantsStarted 2021-09-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Chinese ethnicity
* Subjects seeking for chin volume augmentation
* Per Investigator's assessment, subjects who require 1 to 4 mL total volume of STYLAGE® XXL for chin augmentation to achieve a meaningful improvement and/or change in their aesthetic appearance.
* With realistic expectations who can understand and comply with the instructions and all visit schedule.
* Willing to abstain from other facial cosmetic procedures (e.g., further augmentation therapy, botulinum toxin injections, laser or chemical skin resurfacing, or face lift procedures) below the level of the horizontal line from subnasale for the duration of the study.
* Women of childbearing potential (WOCBP) who agree contraception during the study period.
* Subjects who voluntarily decided the participation of the study and signed the informed consent.
* Being able to stand mild pain.
Exclusion Criteria:
* Subjects who are contraindicated to injection with HA fillers.
* Subjects who had a history of keloid formation or hypertrophic scar.
* Subjects presenting a scar or skin disorder (e.g., active dermal disease \[facial psoriasis, eczema, rosacea, perioral dermatitis, acne, herpes, etc\], inflammation or an unhealed wound) below the level of the horizontal line from subnasale that may confound the study evaluation.
* Has ever received permanent (non-biodegradable) or semi-permanent fillers or permanent facial implants (e.g., calcium hydroxyapatite, poly-L-lactic acid, polymethylmethacryl…