A 52-week Clinical Investigation of Princess® VOLUME PLUS Lidocaine in Subjects With Midface Volume Deficit (PRIMAvera)

A Prospective, Multi-center, Non-comparative, 52-week Follow-up, Post-market Clinical Investigation of Princess® VOLUME PLUS Lidocaine in Subjects With Midface Volume Deficit

This investigation aims to confirm the safety and effectiveness of Princess VOLUME PLUS Lidocaine in midface volume deficit augmentation and includes a long term safety followup.

Study Overview

• Status: Completed
• Conditions: Midface Volume Deficit
• Intervention / Treatment: Device: Dermal filler for midface deficit

Detailed Description

This non-interventional study will evaluate subjects treated with Princess VOLUME PLUS Lidocaine for midface volume deficit augmentation. A touch-up treatment will be allowed, on discretion of the treating investigator, if the initial treatment didn't provide optimal correction. The effectiveness parameters will be evaluated based on a validated scale for midface volume deficit scale and confirmed by use of patient reported outcome questionnaires as well as based on photographs to be evaluated by an independent evaluator.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1010
    • Yuvell
  • Vienna, Austria, 1010
    • Medizinisch Ästhetisches Zentrum Wien
• Germany
  • Berlin, Germany, 10707
    • RZANY & HUND, Privatpraxis
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Rosenpark Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects suffering from moderate to severe midface volume deficit and having healthy skin in the treatment area.

Description

Inclusion Criteria:

1. Male or female, 18 years of age or older;
2. Presence of bilateral, approximately symmetric moderate to severe midface volume deficit, corresponding to MVDSS grades 2-3;
3. A negative urine pregnancy test at Visit 1 and commitment to use an adequate method of birth control for the duration of the clinical investigation (for women of childbearing potential only);
4. Healthy skin in the midface area and free of diseases that could interfere with evaluation of cutaneous aging or represent a risk for injection;
5. Willingness to abstain from any other aesthetic or surgical procedures in the treatment area for the duration of the investigation, including botulinum toxin injections (except glabella or forehead botulinum toxin treatment);
6. Capable to understand information about the investigation, including subjects' obligations, and is willing to take part, as evidenced by signed and dated informed consent.

Exclusion Criteria:

1. Presence or history of hypertrophic scarring, pigment disorders or keloid formation.
2. Presence or history of any autoimmune disease or current treatment with immune therapy.
3. History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amide-type local anaesthetics.
4. Previous treatment with a permanent filler in the area to be treated.
5. Pregnant or breastfeeding women.
6. Treatment with anticoagulants and platelet aggregation inhibitors (e.g., acetylsalicylic acid) within 10 days prior to Visit 1, unless the risk of bleeding/bruising is discharged after consultation with subject's physician who had prescribed such medicine.
7. Cutaneous, inflammatory and/or infectious processes (e.g., acne, herpes) in the area to be treated.
8. Laser therapy, dermabrasion or mesotherapy within 12 months, or chemical peeling within 3 months prior to Visit 1.
9. History of other aesthetic/surgical treatment which may interfere with performance evaluation.
10. Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study.
11. Previous enrolment in this clinical investigation.
12. Any person dependent on the investigator (e.g., employees, relatives, or similar), or employees of the investigation site institution or the Sponsor.

13. The following subjects shall not participate: persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants (for Austria this is specified in the Medical Devices Act).

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dermal filler for midface deficit; There will be one group in this study, the actual treatment group.	Device: Dermal filler for midface deficit; During this procedure the device (a dermal filler) will be deep intradermal, subcutaneous or supraperiosteal injected according to its CE mark.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary performance endpoint	Response rate at week 4 based on investigator's midface volume deficit severity scale (MVDSS) assessment, where response is defined as a MVDSS grade improvement by ≥1 grade compared to baseline.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary performance endpoint 1	Response rate based on investigator's midface volume deficit severity scale (MVDSS) assessment.	12, 24, 36 and 52 weeks
Secondary performance endpoint 2	Global aesthetic improvement scale (GAIS) grade determined by the investigator.	4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 3	Global aesthetic improvement scale (GAIS) grade determined by the subject.	4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 4	Subject satisfaction.	4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 5	Response rate, based on midface volume deficit severity scale (MVDSS) assessment by the independent photography reviewer.	4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 6	Proportion of subjects with a midface volume deficit severity scale (MVDSS) grade improvement by ≥2 grades.	4, 12, 24, 36 and 52 weeks

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH
• Collaborators: FGK Clinical Research GmbH
• Investigators: Study Director: Martin Prinz, Mag., Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): July 24, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CPH-401-201331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No