Study of STYLAGE® XXL for Volume Deficiency in the Mid-Face (NCT05355454) | Clinical Trial Compass
CompletedNot Applicable
Study of STYLAGE® XXL for Volume Deficiency in the Mid-Face
France90 participantsStarted 2022-06-06
Plain-language summary
The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.
Who can participate
Age range30 Years – 65 Years
SexALL
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Inclusion Criteria:
* Aged between 30 and 65 years
* Seeking correction of his/her mid-face volume deficit, and agrees with recommendation by the Investigator
* Accept the obligation not to receive any other facial procedures or treatments impacting facial volume augmentation at any time during the study
* Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator
* Psychologically able to understand the study related information and to give a written informed consent
* Have voluntarily provided written informed consent to participate in the study, and use of data privacy (sign the ethics committee approved Informed Consent Form), prior to any study-related procedure being performed
* Female of childbearing potential (sexually active, not sterile, nor postmenopausal for at least 1 year) must have a negative urine pregnancy test (UPT) at Visit 1 (or Visit 1b), and use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and for the duration of the study
* Affiliated to a health social security system (for France only)
Exclusion Criteria:
In terms of population:
* Pregnant or breastfeeding woman, or planning a pregnancy during the study
* Scars, moles, tattoo, or anything on the face which might interfere with the evaluation
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship
* Subject in a social or sanitary establ…