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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Nasolabial Folds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Princess® VOLUME

Injection of Princess® VOLUME into the deep dermis or subcutis of both nasolabial folds.

A touch-up treatment may be performed at Day 14 if correction is not complete after the first injection.

The injected volumes will be estimated by the investigator and depend on the depth of the nasolabial folds

Group Type EXPERIMENTAL

Princess® VOLUME

Intervention Type DEVICE

Interventions

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Princess® VOLUME

Intervention Type DEVICE

Other Intervention Names

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highly cross-linked, viscoelastic hyaluronic acid injectable gel implant

Eligibility Criteria

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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)

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No