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

NCT ID: NCT03611491

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-20
• Study Completion Date: 2018-11-19

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.

Conditions

Correction of Nasolabial Folds

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Princess® FILLER Lidocaine

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

Group Type: EXPERIMENTAL

Princess FILLER Lidocaine

Intervention Type: 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.

Interventions

Princess FILLER Lidocaine

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female 18 years of age or older

2. 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

3. Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation

4. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation

5. Written signed and dated informed consent

Exclusion Criteria

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

1. Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)

2. History of mental disorders or emotional instability

3. History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic

4. Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region

5. 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

6. Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region

7. Cutaneous lesions in the treatment area

8. Known human immune deficiency virus-positive individuals

9. History of allergies against aesthetic filling products and recurrent herpes simplex

10. Tendency to hypertrophic scars, keloid formation and/or pigmentation disorders

11. History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy

12. Diabetes mellitus or uncontrolled systemic diseases

13. Use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection

14. Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study

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

16. Previous enrolment in this clinical investigation

17. 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Croma-Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien

Vienna, , Austria

Yuvell

Vienna, , Austria

Countries

Austria

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CPH-401-201324

Identifier Type: -

Identifier Source: org_study_id