Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds

NCT03050710 | Completed Results

• 1 other identifier: CPH-401-201258
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

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.

Conditions

Nasolabial Fold, Hypoplastic

Outcome Measures

Primary Outcomes (2)

• NLF-SRS Grade of Nasolabial Folds Change

  The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator. The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective

  24 weeks

• NLF-SRS Grade of Nasolabial Folds Reduction

  The proportion of subjects with the NLF-SRS grade reduced by ≥1 point at week 24 versus baseline. The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective

  24 weeks

Secondary Outcomes (6)

• NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints

  Week 4, Week 36

• NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints

  week 4, week 36

• Aesthetic Improvement

  week 4, week 24, week 36

• Subjects' Satisfaction With Aesthetic Outcome

  week 4, week 24, week 36

• Pain Intensity

  Day 1, Day 15

Other Outcomes (1)

• Safety Events

  From day 0 until patient last visit / week 36

Study Arms (1)

Princess® VOLUME Lidocaine

OTHER

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

Device: Princess® VOLUME Lidocaine

Interventions

Princess® VOLUME Lidocaine DEVICE

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

Princess® VOLUME Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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 Nasolabial Folds Severity Rating Scale (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:

• 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 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
• 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 and/or keloid formation
• 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 10 days pre- to 3 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
• Previous enrolment in this clinical investigation

Sponsors & Collaborators

• Croma-Pharma GmbH: lead

Study Sites (3)

Medical University Graz

Graz, Austria

Location

MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien

Vienna, Austria

Location

Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch

Vienna, Austria

Location

Results Point of Contact

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

clinical.studies@croma.at

+43 0226268468

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

Model Details: Princess® VOLUME Lidocaine for the correction of nasolabial folds

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: December 27, 2016
• Primary Completion: July 18, 2017
• Study Completion: October 17, 2017
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)