Status:
COMPLETED
Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds
Lead Sponsor:
Croma-Pharma GmbH
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Nasolabial Folds
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief 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
Inclusion
- Major
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01798498
Start Date
April 1 2013
End Date
June 1 2014
Last Update
February 25 2025
Active Locations (3)
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1
Medical University Graz
Graz, Austria
2
Ordination 1
Vienna, Austria
3
Ordination 2
Vienna, Austria