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

Not Applicable

Completed

Conditions: Nasolabial Folds

Interventions: Device: Princess® VOLUME

Registration Number: NCT01798498

Lead Sponsor: Croma-Pharma GmbH

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Princess® VOLUME	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

Primary Outcome Measures

Name	Time	Method
Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180	From Day 0 to Day 180	The primary efficacy endpoint was the absolute change in MFWS from Day 0 to Day 180 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth

Secondary Outcome Measures

Name	Time	Method
Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270	Day 0 to Days 30, 90, and 270	The change in absolute Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 was additionally assessed at Days 30, 90, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth
Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)	Days 30, 90, 180, and 270	Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) at Days 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth
Subject Satisfaction	Days 30, 90, 180, and 270	Subject satisfaction at Days 30, 90, 180, and 270 To assess subject's satisfaction, subjects were asked to indicate their level of satisfaction on 3- or 5-point scales as follows: * Question 1: How would you judge the change of your appearance after treatment (asked at Days 30, 90, 180, and 270): 1. Very much improved 2. Much improved 3. Slightly improved 4. No change 5. Worsened * Question 2: How satisfied are you with the treatment (to be asked at Days 30 and 270): 1. Very satisfied 2. Satisfied 3. Not satisfied * Question 3: Would you recommend the treatment to your friends and acquaintances (to be asked at Days 30 and 270): 1. Yes 2. Perhaps 3. No
Global Aesthetic Improvement Scale (GAIS)	Days 14, 30, 90, 180, 270	Investigator rating of aesthetic improvement based on GAIS The GAIS is a 5-point scale that rates global aesthetic improvement in appearance, compared to pre-treatment, as judged by the investigator. The rating categories were 'worse', 'no change', 'improved', 'much improved', and 'very much improved'.