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

Croma-Pharma

Status: Completed

Conditions: Nasolabial Folds

Treatments: Device: Princess® VOLUME

Study type: Interventional

Funder types: Industry

Identifiers

NCT01798498

PVN1

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Princess® VOLUME

Experimental group

Description:

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

Treatment:

Device: Princess® VOLUME