Nasolabial FoldsNCT01798498

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

A study testing Princess® VOLUME in people with Nasolabial Folds, run by Croma-Pharma GmbH at 3 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Nasolabial Folds
What is being tested?: Princess® VOLUME
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 3 sitesAustria
Study dates: Apr 2013to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

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 locations and contacts

3 sites in 1 country.

Austria3 sites

Medical University Graz
Graz
Ordination 1
Vienna
Ordination 2
Vienna

Other trials in Austria

About this study

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

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

Conditions: Nasolabial Folds
Being tested: Princess® VOLUME

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Princess® VOLUMEDevice
Also called highly cross-linked, viscoelastic hyaluronic acid injectable gel implant

Study groups in NCT01798498
Study group	Role	What they receive
Princess® VOLUME	Experimental	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 Receives: Device: Princess® VOLUME

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Modified Fitzpatrick Wrinkle Scale (MFWS) 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
Measured: From Day 0 to Day 180

Secondary outcomes (4)

Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From 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
Measured: Day 0 to Days 30, 90, and 270
Percentage of Subjects With an 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 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
Measured: Days 30, 90, 180, and 270
Subject Satisfaction
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
Measured: Days 30, 90, 180, and 270
Global Aesthetic Improvement Scale (GAIS)
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'.
Measured: Days 14, 30, 90, 180, 270

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Jun 2014

First posted26 Feb 2013 (estimated)
Study startApr 2013
Primary completionApr 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nasolabial FoldsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01798498
Sponsor's protocol ID: PVN1
Status last verified: Dec 2024
First submitted: 22 Feb 2013
Last updated: 25 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
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Not yet recruiting
Dermal Evaluation of Facetem™ S in Nasolabial Folds Esthetics Improvement: DEFINE Study
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Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
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Study to Assess Adverse Events and How Effective NOA LIFT is Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds in Adults
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Recruiting
THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit

All Nasolabial Folds trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds
ClinicalTrials.gov ID: NCT01798498
Acronym / sponsor ID: PVN1
Conditions: Nasolabial Folds
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Croma-Pharma GmbHIndustry (pharma, biotech, devices)
Collaborators: FGK Clinical Research GmbH
Study start: Apr 2013
Primary completion: Apr 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 26 Feb 2013 (estimated)
Results: Posted 25 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Princess® VOLUME	Experimental	Device: Princess® VOLUMEInjection 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

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Princess® VOLUMEAlso: highly cross-linked, viscoelastic hyaluronic acid injectable gel implant	Device	Princess® VOLUME

Primary outcome

Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180
Time frame: 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

4 secondary outcomes

Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270
Time frame: Day 0 to Days 30, 90, and 270
Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)
Time frame: Days 30, 90, 180, and 270
Subject Satisfaction
Time frame: Days 30, 90, 180, and 270
Global Aesthetic Improvement Scale (GAIS)
Time frame: Days 14, 30, 90, 180, 270

Results and safety

Results posted to the registry on 25 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Princess® VOLUME	48	47

Primary outcome: Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180

Time frame: From Day 0 to Day 180. Mean (Standard Deviation). Unit: score on a scale

Measure	Princess® VOLUME n = 47
Value	-1.309 (0.373)

Population analysed: safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once. The mean of both measurements (right/left nasolabial fold) is used.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Princess® VOLUME	1 of 48 (2.1%)	12 of 48 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Nasolabial Folds

Recruiting
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
Nasolabial Folds
Not yet recruiting
Dermal Evaluation of Facetem™ S in Nasolabial Folds Esthetics Improvement: DEFINE Study
Nasolabial Folds
Active, not recruiting
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Nasolabial Fold
RecruitingPhase 3
Study to Assess Adverse Events and How Effective NOA LIFT is Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds in Adults
Nasolabial Folds
Recruiting
THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daisy Kopera, Prof. Dr. principal investigator

Department of Dermatology and Gerontology, Medical University Graz

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Princess® VOLUME in people with Nasolabial Folds, run by Croma-Pharma GmbH at 3 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180 (time frame: From Day 0 to Day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01798498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.