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

Croma-Pharma GmbH2 sites in 1 country74 target enrollmentJuly 10, 2018

ConditionsCorrection of Nasolabial Folds

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Correction of Nasolabial Folds
Sponsor: Croma-Pharma GmbH
Enrollment: 74
Locations: 2
Primary Endpoint: Cohort 2: Improvement of at least 1 point on the Nasolabial Folds Severity Rating Scale (NLF-SRS) based on investigator's live assessment
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 10, 2018

End Date

December 23, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Croma-Pharma GmbH

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Cohort 2: Improvement of at least 1 point on the Nasolabial Folds Severity Rating Scale (NLF-SRS) based on investigator's live assessment

Time Frame: Week 12 compared to baseline

Scale from 0 (=none/ minimal) to 4 (= extreme)

Cohort 1: Frequency, severity, seriousness and causal relationship of AEs

Time Frame: Up to 4 weeks

Cohort 1: Local tolerability assessment based on presence and intensity of erythema, swelling and skin hardening

Time Frame: Up to 4 weeks

5-grade scale ranging from 0 (absent), over 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe)

Secondary Outcomes

Cohort 2: Response rate based on investigator's assessment of Nasolabial Folds Severity Rating Scale (NLF-SRS)(Week 4, 12, 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)
Cohort 2: Mean pain intensity score using the Numeric Pain Rating Scale (NPRS)(Immediately after administration and 15 minutes after treatment)