Clinical trial NCT01798498: Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds
Official title: Open-label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: FGK Clinical Research GmbH
First posted: 2013-02-26
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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

Primary outcomes:
measure: Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180
timeFrame: From Day 0 to Day 180
Secondary outcomes:
measure: Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270
timeFrame: Day 0 to Days 30, 90, and 270
measure: Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)
timeFrame: Days 30, 90, 180, and 270
measure: Subject Satisfaction
timeFrame: Days 30, 90, 180, and 270
measure: Global Aesthetic Improvement Scale (GAIS)
timeFrame: Days 14, 30, 90, 180, 270
Other outcomes:
measure: Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
timeFrame: Day 0 to Day 14, 30, 90, 180, and 270
measure: Improvement in MFWS in One or Both Nasolabial Folds Over Time
timeFrame: Day 0 to Day 30, 90, 180, and 270
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Wien
country: Austria
facility: Ordination 1
city: Wien
country: Austria
facility: Ordination 2
Study officials:
affiliation: Department of Dermatology and Gerontology, Medical University Graz
name: Daisy Kopera, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: