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

Croma-Pharma

Status

Completed

Conditions

Correction of Nasolabial Folds

Treatments

Device: THIODERM STRONG

Study type

Interventional

Funder types

Industry

Identifiers

NCT03650218

CPH-201-201334

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)