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

Correction of Nasolabial Folds Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650218
• Other study ID #: CPH-201-201334
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: December 23, 2019

Study information

• Verified date: August 2018
• Source: Croma-Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Correction of Nasolabial Folds

Intervention

Device:
• THIODERM STRONG
Soft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance.

Locations

Country	Name	City	State
Austria	Medizinsche Universität Graz-Klinikum für Dermatologie und Venerologie	Graz
Austria	Yuvell	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Croma-Pharma GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1: Frequency, severity, seriousness and causal relationship of AEs		Up to 4 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Cohort 2: Subject satisfaction based on Face-Q questionnaire "Satisfaction with Outcome" Scale		Week 4, 12, 24, 36 and 52 compared to baseline
Secondary	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
Secondary	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
Secondary	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