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

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

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.

Study Overview

• Status: Completed
• Conditions: Correction of Nasolabial Folds
• Intervention / Treatment: Device: THIODERM STRONG

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinsche Universität Graz-Klinikum für Dermatologie und Venerologie
  • Vienna, Austria, 1010
    • Yuvell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): December 23, 2019

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CPH-201-201334

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No