Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds

Study Overview
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Brief Summary
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This is a prospective, open label, dose-escalating, multicenter clinical investigation to evaluate the safety and effectiveness of THIODERM STRONG in the correction of nasolabial folds. The performance is assessed using the 5-point Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 12 compared to baseline.

Official Title
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A Prospective, Open Label, Dose-escalating, Multicenter Clinical Investigation to Evaluate the Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds.

Conditions
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Correction of Nasolabial Folds

Intervention / Treatment
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* Device: THIODERM STRONG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females of childbearing potential must have a negative urine pregnancy test at Screening/ Baseline visit and must agree to use an adequate method of contraception for the duration of the clinical investigation Signed informed consent Moderate to severe nasolabial folds (cohort 2) Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evolution (cohort 2) Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation Exclusion Criteria: For females: pregnant and/ or lactating or planning to become pregnant during the investigation History of allergies or hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-basede anesthetic Tendency to keloid formation and/ or hypertrophic scars Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated Recurrent herpes simplex in the treatment area History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy Diabetes mellitus or uncontrolled systemic diseases History of bleeding disorder and/ or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post-injection Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the investigator Previous enrollment in this clinical investigation Current participation in another clinical investigation, or treatment with any investigational drug/ medical device within 30 days prior to clinical investigation enrollment, or five half-lives of the investigational drug, whichever is longer Any dependency of the subject to the investigator or investigation site, or subjects who are employees or relatives of the investigator Subjects whose participation in clinical investigations is prohibited by the Austrian Medical Devices Act Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance in the area of device application (cohort 2) Implantation of facial dermal fillers in the treatment area in the preceding 12 months (cohort 2) Skin of the nasolabial region affected by aesthetic treatments or planning to undergo such procedures during the clinical investigation (cohort 2) Facial lipolysis, including submental fat treatments within last month prior to enrollment or planned during the clinical investigation (cohort 2) Bariatric surgery within 12 months prior to enrollment or planned during the clinical investigation (cohort 2) Planned dental/ oral surgery or modification within two weeks prior to injection and to a minimum of four weeks post injection (cohort 2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THIODERM STRONG<br>THIODERM STRONG injected into the upper arm (cohort 1) THIODERM STRONG injected into nasolabial folds (cohort 2) | Device: THIODERM STRONG<br>* Soft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1: Frequency, severity, seriousness and causal relationship of AEs |  | Up to 4 weeks | 
| Cohort 1: Local tolerability assessment based on presence and intensity of erythema, swelling and skin hardening | 5-grade scale ranging from 0 (absent), over 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) | Up to 4 weeks | 
| Cohort 2: Improvement of at least 1 point on the Nasolabial Folds Severity Rating Scale (NLF-SRS) based on investigator's live assessment | Scale from 0 (=none/ minimal) to 4 (= extreme) | Week 12 compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS) | Scale from 0 (=none/ minimal) to 4 (= extreme) | Week 4, 24, 36 and 52 compared to baseline | 
| Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the investigator | global aesthetic improvement rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse' | Week 4, 12, 24, 36 and 52 compared to baseline | 
| Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the subject | global aesthetic improvement rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse' | Week 4, 12, 24, 36 and 52 compared to baseline | 
| Cohort 2: Subject satisfaction based on Face-Q questionnaire Satisfaction with Outcome Scale |  | Week 4, 12, 24, 36 and 52 compared to baseline | 
| Cohort 2: Response rate based on blinded photographic reviewer's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS) | Scale from 0 (=none/ minimal) to 4 (= extreme) | Week 4, 12, 24, 36 and 52 compared to baseline | 
| Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS) | Scale from 0 (=none/ minimal) to 4 (= extreme) | Week 4, 12, 24, 36 and 52 compared to baseline | 
| Cohort 2: Mean pain intensity score using the Numeric Pain Rating Scale (NPRS) | 11-point scale ranging from 0 (= no pain) to 10 (=worst pain imaginable) | Immediately after administration and 15 minutes after treatment |