Lip; Anomaly Clinical Trial
Official title:
A Pivotal, Randomized, Subject- and Evaluator-blinded, Controlled, Non-inferiority, Multicenter, Parallel Group Comparison Study to Evaluate Effectiveness and Safety of THIODERM ELATE for Lip Augmentation in Order to Correct Lip Volume Deficit
A pivotal, randomized, subject- and evaluator-blinded, controlled, non-inferiority, multicenter, parallel group comparison study to evaluate effectiveness and safety of THIODERM ELATE for lip augmentation in order to correct lip volume deficit
The clinical investigation will comprise randomization to one of two treatment groups: - Test device: THIODERM ELATE - Comparator device: Juvéderm® ULTRA 3 The Screening visit (Visit 1) will be performed within 2 weeks prior to randomization and will entail informed consent and screening assessments. During this visit the treating investigator will determine eligibility of subjects based on study inclusion and exclusion criteria - except for Baseline severity of lip volume deficit, that will be determined at Screening visit (Visit 1) by the blinded evaluator at the site using the 5-point LFS. In addition, the subject's face will be photographed to document baseline condition for further assessments. At Baseline visit (Visit 2 / Day 0), eligible subjects will be randomized in a 2:1 ratio and undergo lip augmentation treatment of both, upper and lower lip, with either THIODERM ELATE or Juvéderm® ULTRA 3 (baseline treatment). If an optimal aesthetic correction has not been achieved after the baseline treatment as evaluated by the treating investigator, a touch-up treatment may be performed at Week 4 (Visit 3) using the same device as initially applied at Visit 2. As of Week 36 (Visit 7 (SV1)) after last treatment (either baseline or touch-up treatment) of the initial treatment phase, subjects of both treatment groups (test device and comparator device) may qualify for a repeat-treatment, which will be done with THIODERM ELATE only. Further Screening visits for repeat-treatment may be conducted after Visit 7 (SV1) if the subject does not qualify at Visit 7(SV1) already for repeat-treatment. Screening phase for repeat-treatment will be up to 20 weeks after Visit 7 (SV1) with Visit SV2 (12 weeks after Visit 7 (SV1)), Visit SV3 (16 weeks after Visit 7 (SV1)), and Visit SV4 (20 weeks after Visit 7 (SV1)). As soon as the subject is eligible in LFS score as assessed by the blinded evaluator at the site, a full eligibility assessment for repeat-treatment will be done by the treating investigator. Subjects do not have to return to their baseline severity of lip volume deficit to be eligible and receive a repeat-treatment, but the present condition of lip volume deficit must meet the initial inclusion criterion (very thin lips or thin lips or moderately thick lips in both lips). The blinded evaluating investigator at the site decides if a subject is eligible for the repeat-treatment (regarding LFS). Visit SV4 (20 weeks after Visit 7 (SV1)) will be the end of investigation visit for subjects who do not qualify for repeat-treatment. In case an inclusion criterion is not met / an exclusion criterion is met for repeat-treatment and further follow up in screening is not useful because the subject will apparently not qualify for repeat-treatment, the respective Screening Visit (SV1, SV2, SV3, or SV4) will be the end of investigation visit for the respective subject. Subjects who are eligible and undergo repeat-treatment at Visit RT1 will enter the repeat-treatment follow-up phase. Subjects may receive a touch-up treatment after 4 weeks (Visit RT2) based on the treating investigator's judgement. The follow-up period will be 24 weeks after the last treatment (initial repeat treatment or touch-up treatment, respectively). Follow-up visits on-site will occur at: - Initial treatment phase: Week 4 and Week 8 after baseline treatment, and 12, 24, and 36 weeks after last treatment, i.e., baseline or touch-up treatment, respectively (Visits 3 to 7 (SV1)) - Screening phase for repeat-treatment: Week 12, 16 and 20 after Visit 7 (SV1) - (Visits SV2 to SV4) - Repeat-treatment phase: Week 4, 8, 12, and 24 after initial repeat-treatment (Visits RT2 to RT5) regardless of whether a touch-up treatment has been performed or not (Visit RT2 to RT5) In addition to the on-site follow-up visits, 24-48 hours after each treatment the subjects will be contacted by phone for safety checkup. If applicable, the incidence, severity, seriousness, and type of adverse events resulting from device injection will be determined and closely followed up until resolution. Lip volume deficit will be evaluated (live assessment) by the blinded evaluator at the site using the 5-point LFS during follow-up visits of the initial and repeat-treatment phase. In addition, volume change measurements will be done on 3D photographs. Subject's pain perception during treatment and recovery from treatment will be evaluated by means of a numerical pain rating scale (NPRS) immediately after, and 15 and 30 minutes after last injection of each treatment session. Global aesthetic improvement will be evaluated by reviewing and comparing current photographs relative to photographs taken at Screening visit. Both - the blinded evaluator at the site and the subject - will assess the global aesthetic improvement (using the modified GAIS) at each on-site visit after subject was fully treated (baseline and touch-up treatment, as applicable) during the initial treatment phase. Subject´s satisfaction with the outcome of the treatment will be assessed with the FACE-QTM questionnaires "Satisfaction with Outcome" and "Satisfaction with Lips" at each on-site visit after subject was fully treated (baseline / repeat-treatment and touch-up treatment, as applicable) during the initial and repeat-treatment phase, respectively. Subject´s "Satisfaction with Lips" will also be assessed at Visit 2 (Baseline visit) and Visit RT1. The safety will be evaluated based on occurrence of adverse events, which will be collected at each visit (on-site and telephone visits) throughout the clinical investigation, beginning after signature of the ICF until the last visit. To identify potential adverse events post-administration a safety evaluation after 30 minutes needs to take place. A subject diary will be used to record injection site reactions, and symptoms of interest (i.e., vaso-occlusive events, such as changes in vision or symptoms of stroke) over the first four weeks (28 days) after each treatment (i.e., either 4 weeks after baseline and repeat-treatment or in total 8 weeks in case of touch-up treatment). To evaluate any potential vision changes, visual examinations (including Snellen visual acuity, confrontational visual fields and ocular motility) will be additionally performed at treatment visits (prior to- and 30 min after any treatment) and at all follow-up visits of the initial and repeat-treatment phase. A basic neurological examination (F.A.S.T) will be performed for all subjects who show signs of ophthalmic complications due to filler injection. Abnormal clinically significant changes in visual examination or experience of neurological symptoms indicative of a vaso-occlusive event after any treatment will lead to withdrawal of the subject from further treatment(s) in case an eye specialist or neurologist confirms that the result is related to a vascular injection of the dermal filler. The subjects may remain in the study for at least safety assessments during the scheduled study visits. In such case, stopping the entire investigation will be reviewed. ;