Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds

NCT ID: NCT03050710

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-27
• Study Completion Date: 2017-10-17

Brief Summary

In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME 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

This is a prospective, open label, multicenter, post-market investigation. Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME 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. The performance of the investigational device will be 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 treatment and in comparison to Day 0), global aesthetic improvement (4, 24 and 36 weeks after the treatment). The subject will evaluate pain intensity associated with the treatment (at Day 0 and at Week 2 (if Touch-up treatment occurred)), and satisfaction with the treatment 4, 24 and 36 weeks after the treatment.

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

Conditions

Nasolabial Fold, Hypoplastic

Study Design

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

Study Groups

Princess® VOLUME Lidocaine

Princess® VOLUME Lidocaine is administered by injection into the deep dermis or subcutis. The volume applied depends on the size of the area which requires correction and will be selected by the investigator, but will not exceed 10 mL in total per treatment. A single application, with optional Touch-up treatment after two weeks, if the desired level of correction has not been achieved with the initial applicatio

Group Type: OTHER

Princess® VOLUME Lidocaine

Intervention Type: DEVICE

Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable

Interventions

Princess® VOLUME Lidocaine

Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable

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 Nasolabial Folds Severity Rating Scale (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

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 nonabsorbable sutures (thread), laser therapy, dermoabrasion, or botulinum toxin application in the nasolabial region within previous 12 months, or chemical peeling within previous 3 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 and/or keloid formation

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 10 days pre- to 3 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: No

Sponsors

Croma-Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University Graz

Graz, , Austria

MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien

Vienna, , Austria

Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch

Vienna, , Austria

Countries

Austria

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CPH-401-201258

Identifier Type: -

Identifier Source: org_study_id