Correction of Nasolabial Folds
Conditions
Brief summary
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.
Interventions
DEVICETHIODERM STRONG
Soft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance.
Sponsors
Croma-Pharma GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 4 weeks | 5-grade scale ranging from 0 (absent), over 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) |
| Cohort 2: Improvement of at least 1 point on the Nasolabial Folds Severity Rating Scale (NLF-SRS) based on investigator's live assessment | Week 12 compared to baseline | Scale from 0 (=none/ minimal) to 4 (= extreme) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS) | Week 4, 24, 36 and 52 compared to baseline | Scale from 0 (=none/ minimal) to 4 (= extreme) |
| Cohort 2: Mean pain intensity score using the Numeric Pain Rating Scale (NPRS) | Immediately after administration and 15 minutes after treatment | 11-point scale ranging from 0 (= no pain) to 10 (=worst pain imaginable) |
| Cohort 2: Response rate based on blinded photographic reviewer's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS) | Week 4, 12, 24, 36 and 52 compared to baseline | Scale from 0 (=none/ minimal) to 4 (= extreme) |
| Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the investigator | Week 4, 12, 24, 36 and 52 compared to baseline | global aesthetic improvement rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse' |
| Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the subject | Week 4, 12, 24, 36 and 52 compared to baseline | global aesthetic improvement rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse' |
Countries
Austria
Outcome results
None listed