Clinical trial NCT03050710: Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
Official title: A Prospective, Open-label, Multicenter, Post-market Study Evaluating Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Fold, Hypoplastic
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2017-02-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Princess® VOLUME Lidocaine for the correction of nasolabial folds
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: NLF-SRS Grade of Nasolabial Folds Change
timeFrame: 24 weeks
measure: NLF-SRS Grade of Nasolabial Folds Reduction
timeFrame: 24 weeks
Secondary outcomes:
measure: NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints
timeFrame: Week 4, Week 36
measure: NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints
timeFrame: week 4, week 36
measure: Aesthetic Improvement
timeFrame: week 4, week 24, week 36
measure: Subjects' Satisfaction With Aesthetic Outcome
timeFrame: week 4, week 24, week 36
measure: Pain Intensity
timeFrame: Day 1, Day 15
measure: NLF-SRS Grade of Nasolabial Folds Reduction- Imaging Independent Reviewer
timeFrame: Week 24
Other outcomes:
measure: Safety Events
timeFrame: From day 0 until patient last visit / week 36
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Wien
country: Austria
facility: MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien
city: Wien
country: Austria
facility: Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch
Study officials:
References: