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

NCT03650218 | Completed

• 1 other identifier: CPH-201-201334
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Correction of Nasolabial Folds

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

• Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the investigator

  Week 4, 12, 24, 36 and 52 compared to baseline

• Cohort 2: Gloabl aesthetic improvement scale (GAIS) determined by the subject

  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)

  Week 4, 12, 24, 36 and 52 compared to baseline

Study Arms (1)

THIODERM STRONG

EXPERIMENTAL

THIODERM STRONG injected into the upper arm (cohort 1) THIODERM STRONG injected into nasolabial folds (cohort 2)

Device: THIODERM STRONG

Interventions

THIODERM STRONG DEVICE

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

THIODERM STRONG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (2)

Medizinsche Universität Graz-Klinikum für Dermatologie und Venerologie

Graz, 8036, Austria

Location

Yuvell

Vienna, 1010, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 28, 2018
• Study Start: July 10, 2018
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

AU (2)