Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds

Nasolabial Folds Clinical Trial

Official title:

Open-label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798498
• Other study ID #: PVN1
• Status: Completed
• Phase: N/A
• First received: February 22, 2013
• Last updated: July 29, 2014
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Croma-Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME for the correction of nasolabial folds.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• Princess® VOLUME

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Austria	Ordination	Wien

Sponsors (2)

Lead Sponsor	Collaborator
Croma-Pharma GmbH	FGK Clinical Research GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Day 180		Day 180	No
Secondary	Change in Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Days 30, 90, and 270		Days 30, 90, and 270	No
Secondary	Improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)	Percentage of subjects with an improvement of at least 0.5 on the MFWS at Days 30, 90, 180 and Day 270	Days 30, 90, 180 and Day 270	No
Secondary	Subject satisfaction	Subject satisfaction at Days 30, 90, 180, and 270	Days 30, 90, 180, and 270	No
Secondary	Global Aesthetic Improvement	Global Aesthetic Improvement Scale (GAIS) at Days 30, 90, 180, and 270	Days 30, 90, 180, and 270	No
Secondary	Adverse events		Days 0, 14, 30, 90, 180, 270	Yes