Post Market Study Evaluating Princess Filler Lidocaine for the Correction of Nasolabial Folds

Not Applicable

Completed

Conditions: Correction of Nasolabial Folds

Interventions: Device: Princess FILLER Lidocaine

Registration Number: NCT03611491

Lead Sponsor: Croma-Pharma GmbH

Brief Summary: In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® FILLER Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator

Detailed Description: A prospective, open label, multicenter, post-market investigation. Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds were treated with Princess® FILLER Lidocaine, and were to return for follow-up assessments 2, 4, 24 and 36 weeks after the initial treatment. A Touch-up treatment may be done at Week 2 after initial treatment, if deemed appropriate by the investigator. The performance of the investigational device evaluated by the investigator by assessing severity of nasolabial folds using the Nasolabial Folds Severity Rating Scale (NLF-SRS) (4, 24 and 36 weeks after the initial treatment and in comparison to Day 0) and global aesthetic improvement (4, 24 and 36 weeks after the initial treatment). The subject evaluated pain intensity associated with the treatment (at Day 0 and at Week 2 after initial treatment (if Touch-up treatment occurred)), and satisfaction with the treatment 4, 24 and 36 weeks after the initial treatment.

The safety was evaluated based on occurrence of adverse events, which were collected throughout the investigation.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Male or female 18 years of age or older
Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds scored 2-3 according to the 5-grade NLF-SRS as assessed by the investigator
Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
Written signed and dated informed consent

Exclusion Criteria

Subjects meeting any of the following criteria should not be enrolled:

Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
History of mental disorders or emotional instability
History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
Facial surgery or implantation of dermal fillers, absorbable and non-absorbable sutures, laser therapy, dermabrasion, or botulinum toxin application in the nasolabial region within previous twelve months, or chemical peeling within previous three months, or planning to undergo such procedures in the treatment area during the study
Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
Cutaneous lesions in the treatment area
Known human immune deficiency virus-positive individuals
History of allergies against aesthetic filling products and recurrent herpes simplex
Tendency to hypertrophic scars, keloid formation and/or pigmentation disorders
History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
Diabetes mellitus or uncontrolled systemic diseases
Use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection
Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study
Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study
Previous enrolment in this clinical investigation
Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Princess® FILLER Lidocaine	Princess FILLER Lidocaine	Princess FILLER Lidocaine injections up to 10 ml given to the patients at baseline time point

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24	Baseline and Week 24	Change from baseline in average Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at week 24 after the initial treatment. The left and right nasolabial folds were graded separately on the 5-point NLF-SRS then the average of the two sides was used for analysis. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24	Week 24	The proportion of subjects with at least 1 point reduction from baseline in Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at week 24 after the initial treatment. The left and right nasolabial folds were graded separately. A subject is counted if the subject had at least one grade reduction over baseline on both nasolabial folds, on the 5-point NLF-SRS. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Weeks 4 and 36	Baseline, Week 4, Week 36	Change from baseline in average Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at weeks 4 and 36 after the initial treatment. The left and right nasolabial folds were graded separately on the 5-point NLF-SRS then the average of the two sides was used for analysis. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Weeks 4 and 36	Week 4, Week 36	The proportion of subjects with at least 1 point reduction from baseline in Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on investigator assessment at weeks 4 and 36 after the initial treatment. The left and right nasolabial folds were graded separately. A subject is counted if the subject had at least one grade reduction over baseline on both nasolabial folds, on the 5-point NLF-SRS. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Satisfaction of Subjects With Aesthetic Outcome at Weeks 4, 24 and 36	Week 4, Week 24, Week 36	Summary of subjects' satisfaction with aesthetic outcome of the treatment at weeks 4, 24 and 36 after the initial treatment. Subjects were asked to rate their satisfaction with the treatment using one of the following categories: 'very unsatisfied', 'unsatisfied', 'neither unsatisfied nor satisfied', 'satisfied', or 'very satisfied'.
Average Pain Intensity Based on Subject Assessment Immediately After the Last Injection and 15 Minutes Thereafter for Initial and Touch-up Treatment	Baseline - Immediately after end of treatment, 15 minutes after end of treatment Week 2 - Immediately after end of treatment, 15 minutes after end of treatment	Average pain intensity based on subject assessment immediately after the last injection and about 15 minutes thereafter for initial treatment at baseline and for touch-up treatment at week 2 (if applicable). Subjects quantified the pain associated with the procedure using a semi-quantitative 11-point Numeric Pain Rating Scale (NPRS): 0 is no pain and 10 is the worst pain you can imagine.
Proportion of Subjects With Aesthetic Improvement Based on Investigator Assessment at Weeks 4, 24 and 36	Week 4, Week 24, Week 36	The proportion of subjects with an aesthetic improvement over baseline (subjects who have been rated as "very much improved" or "much improved" or "improved" on both nasolabial folds), based on investigator assessment at weeks 4, 24 and 36 after the initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse".
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Independent Reviewer Assessment of Photographs at Week 24	Week 24	The proportion of subjects with at least 1 point reduction from baseline in Nasolabial Folds-Severity Rating Scale (NLF-SRS) grade based on independent reviewer assessment of photographs at week 24 after the initial treatment. The left and right nasolabial folds were graded separately. A subject is counted if the subject had at least one grade reduction over baseline on both nasolabial folds, on the 5-point NLF-SRS. NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).