Clinical trial NCT03650218: Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds
Official title: A Prospective, Open Label, Dose-escalating, Multicenter Clinical Investigation to Evaluate the Safety and Effectiveness of THIODERM STRONG in the Correction of Nasolabial Folds.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Correction of Nasolabial Folds
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2018-08-28
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cohort 1: Frequency, severity, seriousness and causal relationship of AEs
timeFrame: Up to 4 weeks
measure: Cohort 1: Local tolerability assessment based on presence and intensity of erythema, swelling and skin hardening
timeFrame: Up to 4 weeks
measure: Cohort 2: Improvement of at least 1 point on the Nasolabial Folds Severity Rating Scale (NLF-SRS) based on investigator's live assessment
timeFrame: Week 12 compared to baseline
Secondary outcomes:
measure: Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)
timeFrame: Week 4, 24, 36 and 52 compared to baseline
measure: Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the investigator
timeFrame: Week 4, 12, 24, 36 and 52 compared to baseline
measure: Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the subject
timeFrame: Week 4, 12, 24, 36 and 52 compared to baseline
measure: Cohort 2: Subject satisfaction based on Face-Q questionnaire "Satisfaction with Outcome" Scale
timeFrame: Week 4, 12, 24, 36 and 52 compared to baseline
measure: Cohort 2: Response rate based on blinded photographic reviewer's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)
timeFrame: Week 4, 12, 24, 36 and 52 compared to baseline
measure: Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)
timeFrame: Week 4, 12, 24, 36 and 52 compared to baseline
measure: Cohort 2: Mean pain intensity score using the Numeric Pain Rating Scale (NPRS)
timeFrame: Immediately after administration and 15 minutes after treatment
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinsche Universität Graz-Klinikum für Dermatologie und Venerologie
city: Vienna
country: Austria
facility: Yuvell
Study officials:
References: