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

NCT03611491 | Completed Results

• 1 other identifier: CPH-401-201324
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Correction of Nasolabial Folds

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at 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).

  Baseline and Week 24

• Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at 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).

  Week 24

Secondary Outcomes (6)

• 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

• 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

• Proportion of Subjects With Aesthetic Improvement Based on Investigator Assessment at Weeks 4, 24 and 36

  Week 4, Week 24, Week 36

• Satisfaction of Subjects With Aesthetic Outcome at Weeks 4, 24 and 36

  Week 4, Week 24, Week 36

• 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

Study Arms (1)

Princess® FILLER Lidocaine

EXPERIMENTAL

Princess FILLER Lidocaine injections up to 10 ml given to the patients at baseline time point

Device: Princess FILLER Lidocaine

Interventions

Princess FILLER Lidocaine DEVICE

Princess FILLER Lidocaine injection up to 10 ml given to the patients at baseline time point. After 2 week a touch up is given in case to be consider necessary.

Princess® FILLER Lidocaine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (2)

MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien

Vienna, 1010, Austria

Location

Yuvell

Vienna, 1010, Austria

Location

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: CROMA - PHARMA

clinical.studies@croma.at

+43 2262 68468

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: November 30, 2017
• First Posted: August 2, 2018
• Study Start: September 20, 2017
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2018-01

Locations

AU (2)