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).
The Investigation is an exploratory, prospective, randomized, subject and evaluator-blinded, split- face, single-centre study investigating the effectiveness and safety of THIODERM STRONG compared to Juvéderm® VOLUMA® Lidocaine for the treatment of moderate to severe midface volume deficit. 20 eligible Subjects will be included in this investigation, after the informed consent form (ICF) has been signed and relevant pre-treatment procedures, including medical history and pregnancy testing, have been performed. Subjects will receive injection in the midface region using THIODERM STRONG and Juvéderm® VOLUMA® Lidocaine until an optimal aesthetic result is achieved. The Blinded Evaluating Investigator will determine severity of the Subject's midface volume deficit using the 5-point MVDSS throughout the investigation (Baseline to Week 24). Baseline is defined as the assessment prior to administration of the IMDs. The same Investigator will assess the Subject using the 5-point MVDSS at all visits. An optional touch-up treatment can be performed at Week 4 upon discretion of the Unblinded Treating Investigator. The effectiveness and safety of the treatment will be evaluated after Day 1, 3 and 7 as well as at 4, 8, 16 and 24 weeks using objective and subjective outcome parameters. An interim analysis will be performed when all Subjects have completed the visit at Week 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Test Device
Comparator Device
H&P Ambulatorien GmbH
Vienna, Austria
Response Magnitude
To assess the effectiveness of THIODERM STRONG in reducing the severity of the midface volume deficit in comparison with Juvéderm® VOLUMA® Lidocaine based on Blinded Evaluating Investigator assessment at Week 24 as measured via the 5-point Midface Volume Deficit Severity Scale (MVDSS).
Time frame: 24 Weeks
Total Volume Injected
To assess required total volume for optimum aesthetic result for THIODERM STRONG compared to Juvéderm® VOLUMA® Lidocaine.
Time frame: 24 Weeks
Response Rate
To assess the proportion of responders after treatment with THIODERM STRONG in comparison with Juvéderm® VOLUMA® Lidocaine per treated side.
Time frame: Day7; Week 4, 8, 16, and 24
Response Magnitude
To assess the change on the 5-point MVDSS from baseline after treatment with THIODERM STRONG in comparison with Juvéderm® VOLUMA® Lidocaine.
Time frame: Day 7; Week 4, 8, and 16
Response Magnitude Photographic Review
Change of 5-point MVDSS from baseline to Day 7 and Week 4, 8, 16 and 24 based on the independent blinded evaluating panel's assessment per treated side.
Time frame: Day7; Week 4, 8, 16, and 24
Aesthetic Improvement via GAIS - Investigator
Aesthetic improvement based on the Blinded Evaluating Investigator's assessment per treated side at Week 4, 8, 16 and 24 using the GAIS.
Time frame: Day7; Week 4, 8, 16, and 24
Aesthetic Improvement via GAIS - Subject
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Aesthetic improvement based on the Subject's assessment per treated side at Week 4, 8, 16 and 24 using the GAIS
Time frame: Day7; Week 4, 8, 16, and 24
Volume Change via 3D Imaging
Volume change of the midface region at Day 7 and Week 4, 8, 16 and 24, based on 3D surface imaging in comparison to the baseline 3D surface image per treated side.
Time frame: Day7; Week 4, 8, 16, and 24
Subject Satisfaction - Face-Q(TM) Outcome Scale
The extent of Subject´s satisfaction with treatment of the midface at Day 1, 3, 7 and Week 4, 8, 16 and 24 as assessed by the FACE-QTM Satisfaction with Outcome Scale per treated side.
Time frame: Day 1, 3, and 7; Week 4, 8, 16, and 24
Subject Appearance Appraisal - Face-Q(TM) Satisfaction with Cheeks
The extent of Subject´s appearance appraisal at Day 1, 3, 7 and Week 4, 8, 16 and 24 as assessed by the FACE-QTM Satisfaction with Cheeks Scale per treated side and compared to the score at screening.
Time frame: Day 1, 3, and 7; Week 4, 8, 16, and 24
Change of Nasolabial Fold Severity
Change of nasolabial fold severity measured by NLF-SRS from baseline to Day 7 and Week 4, 8, 16 and 24 based on the Blinded Evaluating Investigator's assessment per treated side.
Time frame: Day7; Week 4, 8, 16, and 24
Pain Assessment
Subject´s pain assessment after each treatment on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable per treated side.
Time frame: Day 0; Week 4 (in case of touch-up treatment)