THIODERM STRONG Compared to Juvéderm® VOLUMA® Lidocaine for the Treatment of Midface Volume Deficit (NCT06128109) | Clinical Trial Compass
CompletedNot Applicable
THIODERM STRONG Compared to Juvéderm® VOLUMA® Lidocaine for the Treatment of Midface Volume Deficit
Austria20 participantsStarted 2023-01-24
Plain-language summary
This mono-center clinical investigation is intended to evaluate the safety and effectiveness of THIODERM STRONG (test device) in the correction of moderate to severe midface volume deficit compared to Juvéderm® VOLUMA® Lidocaine (comparator device).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged ≥ 18 years at the time of screening (upper limit 75 years, inclusive).
✓. Subjects with bilateral, approximately symmetric moderate to severe midface volume deficit (severity scores of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale), shown by the same rating on both sides, assessed by the Blinded Evaluating Investigator.
✓. Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation.
✓. Subject has a stable medical condition with no uncontrolled systemic disease.
✓. Females of childbearing potential must have a negative urine pregnancy test and must agree to use a highly effective method of birth control throughout the entire study1.
✓. Male subjects with female partners of child-bearing potential must agree to use contraception throughout the entire study (surgical sterilization or a physical barrier such as a condom).
✓. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of study, including botulinum toxin injection (except glabella or forehead botulinum toxin treatment).
✓. Subjects who understand the purpose and conduct of the study and having given written informed consent and are willing and able to attend the study visits as judged by the Investigator.
Exclusion criteria
✕. Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation.