This mono-center clinical investigation is intended to assess the safety and effectiveness of THIODERM ELATE for augmentation of very thin and thin lips in comparison with Juvéderm® Ultra 3.
The Investigation is a prospective, exploratory, randomized, subject and evaluator - blinded, parallel-group, single-centre, pilot trial investigating the safety and effectiveness of THIODERM ELATE compared to Juvéderm® Ultra 3 for lip augmentation. Up to 33 eligible subjects will be included in this investigation with a 10 % estimated drop-out rate and will be randomized in a 2:1 ratio to Thioderm ELATE and Juvéderm® Ultra 3, respectively, after the informed consent form (ICF) has been signed and relevant pre-treatment procedures, including medical history and pregnancy testing, as well as eligibility for inclusion have been performed. Subjects will receive injections into both, upper and lower lip using Thioderm ELATE or Juvéderm® Ultra 3 until an optimal cosmetic result is achieved. During Screening and prior to injection, the Blinded Evaluating Investigator will evaluate the lip fullness by using the 5-point Lip Fullness Scale (LFS). An optional touch-up treatment can be performed at Week 4 upon discretion of the treating investigator. The safety and effectiveness of the treatment will be evaluated after Day 1, 3 and 7 as well as at 4, 8,12, 16 and 24 weeks or an End of Study Visit using objective and subjective outcome parameters. . The same Blinded Evaluating Investigator will assess each subject at screening and at the follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
Test Device
Active Comparator Device
H&P Ambulatorien GmbH
Vienna, Austria
Primary Safety Evaluation
Treatment-emergent AEs related to study treatment.
Time frame: through study completion, an average of 24 weeks
Safety Evaluation
Frequency, severity, and causal relationship of adverse events (AEs) and serious adverse events (SAEs) during the entire study period, including adverse device effects (ADEs) and serious adverse device effects (SADEs)
Time frame: through study completion, an average of 24 weeks
Injection Site Reactions (ISR)
Injection site reactions as recorded in the Subject diaries during the first 4 weeks (28 days) after baseline- or touch-up-treatment. Injection site reactions will be assessed overall
Time frame: Week 1-4 (Week 1-8 in case of touch-up treatment)
Responder Rate Week 12
Response measured on the 5-point LFS at Week 12 compared to baseline, based on the Blinded Evaluating Investigator's live assessment where responder is defined as a subject with a ≥1 improvement of the upper lip AND a ≥1 improvement of the lower lip
Time frame: Week 12
Required total Volume of Injection
Required total volume for optimum aesthetic result for treatment of the lip volume deficit at baseline and optional touch - up treatment at Week 4 of the upper and lower lip, as well as for the lip overall.
Time frame: Day 0; Week 4 (in case of touch-up treatment)
Responder Rate
Response measured on the 5-point LFS at Day 7 and Week 4, 8, 16, 24 and End of Study compared to baseline, based on the Blinded Evaluating Investigator's live assessment where a responder is defined as a Subject with a ≥1 improvement on the upper lip AND a ≥ 1 improvement on the lower lip on the 5-point LFS
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Time frame: Day7; Week 4, 8, 16, and 24 and at end of study
Magnitude of Response Upper Lip (Investigator)
Change of 5-point LFS of the upper lip from baseline to Day 7 and Week 4, 8, 12, 16, 24 and at End of Study based on the Blinded Evaluating Investigator's live assessment
Time frame: Day7; Week 4, 8, 12, 16, and 24
Magnitude of Response Lower Lip (Investigator)
Change of 5-point LFS of the lower lip from baseline to Day 7 and Week 4, 8, 12, 16 and 24and at end of study based on the Blinded Evaluating Investigator's live assessment
Time frame: Day7; Week 4, 8, 12, 16, 24 and End of Study
Magnitude of Response Both Lips (Investigator)
Change of 5-point LFS of the overall lip from baseline to Day 7 and Week 4, 8, 12, 16 and 24 and at end of study based on the Blinded Evaluating Investigator's live assessment
Time frame: Day7; Week 4, 8, 12, 16, 24 and End of Study
Magnitude of Response Upper Lip (Independent Photo Review Panel)
Change of 5-point LFS of the upper lip from baseline to Day 7 and Week 4, 8, 12, 16 and 24 based on the independent blinded evaluating panel's assessment
Time frame: Day7; Week 4, 8, 12, 16, and 24
Magnitude of Response Lower Lip (Independent Photo Review Panel)
Change of 5-point LFS of the lower lip from baseline to Day 7 and Week 4, 8, 12, 16 and 24 based on the independent blinded evaluating panel's assessment
Time frame: Day7; Week 4, 8, 12, 16, and 24
Magnitude of Response Both Lips (Independent Photo Review Panel)
Change of 5-point LFS of the overall lip from baseline to Day 7 and Week 4, 8, 12, 16 and 24 based on the independent blinded evaluating panel's assessment
Time frame: Day7; Week 4, 8, 12, 16, and 24
Aesthetic Improvement (Investigator)
Aesthetic improvement based on the Blinded Evaluating Investigator's assessment at Week 4, 8,12, 16 and 24 and at end of study using the GAIS
Time frame: Week 4, 8, 12, 16, 24 and end of stidy
Aesthetic Improvement (Subject)
Aesthetic improvement based on the Subject's assessment at Week 4, 8,12, 16 and 24 and at end of study using the GAIS
Time frame: Week 4, 8, 12, 16, 24 and end od study
Lip Volume Change
Volume change of the lips at Day 7 and Week 4, 8,12, 16 and 24 and at end of study, based on 3D surface imaging in comparison to the baseline 3D image
Time frame: Week 4, 8, 12, 16, 24 and end of study
Subject's satisfaction (Outcome)
The extent of subject´s satisfaction with treatment of the lips at Day 1, 3, 7 and Week 4, 8,12, 16 and 24 and at ebd of study as assessed by the FACE-Q(TM) Satisfaction with Outcome Scale
Time frame: Day 1, 3, 7 and Week 4, 8,12, 16, 24 and end of study
Subject's satisfaction (Lips)
The extent of subject´s appearance appraisal at Day 1, 3, 7 and Week 4, 8,12, 16 and 24 and at end of study as assessed by the FACE-QTM Satisfaction with Lip Scale
Time frame: Day 1, 3, 7 and Week 4, 8,12, 16 24 and end of study
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
Time frame: Day 0; Week 4 (in case of touch-up treatment)