N/A
N=48
Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds
Nasolabial Folds
Bottom Line
View on ClinicalTrials.gov: NCT01798498 ↗Enrolled (actual)
48
Serious AEs
2.1%
Results posted
Feb 2025
Primary outcome: Primary: Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180 — -1.309 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Princess® VOLUME (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Croma-Pharma GmbH
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180 |
-1.309 | — |
| SECONDARY Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270 |
-1.484; -1.436; -1.223 | — |
| SECONDARY Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) |
47; 47; 47; 47 | — |
| SECONDARY Subject Satisfaction |
16; 27; 4; 0; 0; 42 | — |
| SECONDARY Global Aesthetic Improvement Scale (GAIS) |
14; 29; 5; 0; 0; 13 | — |
Summary
The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME for the correction of nasolabial folds.
Eligibility Criteria
Major Inclusion Criteria:
- Male or female subjects between 30 years and 65 years
- Wrinkle score of at least 2 according to the Modified Fitzpatrick Wrinkle Scale (MFWS)
Major Exclusion Criteria:
- For females: pregnancy, lactating, planned pregnancy or unwilling to use contraceptives
- History of allergic reaction to hyaluronic acid products
- Facial surgery or implantation of dermal fillers in the nasolabial region within the last 24 months
- Skin of the nasolabial region affected by cosmetic treatments (e.g. laser therapy within the last 12 months, chemical peeling within the last 3 months, dermabrasion within the last 12 months, botulinum toxin within the last 12 months )
- Connective tissue diseases
- Diabetes mellitus or uncontrolled systemic diseases
- Known human immune deficiency virus-positive individuals
- Presence of silicone implant or another non-absorbable substance (permanent fillers) in the area of product application
- Cutaneous lesions in the evaluated area
- Tendency to keloid formation and/or hypertrophic scars
- Autoimmune disease
- History of allergies against cosmetic filling products and re-current herpes simplex
- History of immune system degradation
Data sourced from ClinicalTrials.gov (NCT01798498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.