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

Correction of Nasolabial Folds Clinical Trial

— FINO  

Official title:

A Prospective, Open Label, Multicenter, Post Market Study Evaluating Princess® FILLER Lidocaine for the Correction of Nasolabial Folds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611491
• Other study ID #: CPH-401-201324
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: November 19, 2018

Study information

• Verified date: January 2018
• Source: Croma-Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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, dermoabrasion, or botulinum toxin application in the nasolabial region within previous twelvemonths, 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)

Related Conditions & MeSH terms

• Correction of Nasolabial Folds

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Austria	MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien	Vienna
Austria	Yuvell	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Croma-Pharma GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator		baseline, Week 24
Secondary	Nasolabial fold severity (NLF-SRS) Weeks 4 and 36	The average change versus Baseline in the NLF-SRS grade at Week 4 and Week 36 after initial treatment as evaluated by the investigator	1 and 9 months post injection