Midface Volume DeficitPRIMAveraNCT03532126
A 52-week Clinical Investigation of Princess® VOLUME PLUS Lidocaine in Subjects With Midface Volume Deficit
An observational study of Midface Volume Deficit, run by Croma-Pharma GmbH at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Midface Volume Deficit
- What is being tested?
- Dermal filler for midface deficit
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 91 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 28 Mar 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects suffering from moderate to severe midface volume deficit and having healthy skin in the treatment area.
Who may be able to join
- Male or female, 18 years of age or older;
- Presence of bilateral, approximately symmetric moderate to severe midface volume deficit, corresponding to MVDSS grades 2-3;
- 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);
- Healthy skin in the midface area and free of diseases that could interfere with evaluation of cutaneous aging or represent a risk for injection;
- 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);
- Capable to understand information about the investigation, including subjects' obligations, and is willing to take part, as evidenced by signed and dated informed consent.
Who cannot join
- Presence or history of hypertrophic scarring, pigment disorders or keloid formation.
- Presence or history of any autoimmune disease or current treatment with immune therapy.
- History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amide-type local anaesthetics.
- Previous treatment with a permanent filler in the area to be treated.
- Pregnant or breastfeeding women.
- 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.
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- Cutaneous, inflammatory and/or infectious processes (e.g., acne, herpes) in the area to be treated.
- Laser therapy, dermabrasion or mesotherapy within 12 months, or chemical peeling within 3 months prior to Visit 1.
- History of other aesthetic/surgical treatment which may interfere with performance evaluation.
- Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study.
- Previous enrolment in this clinical investigation.
- Any person dependent on the investigator (e.g., employees, relatives, or similar), or employees of the investigation site institution or the Sponsor.
- 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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Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Austria2 sites
Medizinisch Ästhetisches Zentrum Wien
Vienna, 1010
Yuvell
Vienna, 1010
Germany2 sites
RZANY & HUND, Privatpraxis
Berlin, 10707
Rosenpark Research
Darmstadt, Hesse, 64283
About this study
Official title: 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.
Read the 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.
- Conditions
- Midface Volume Deficit
- Being tested
- Dermal filler for midface deficit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal filler for midface deficitDevice
During this procedure the device (a dermal filler) will be deep intradermal, subcutaneous or supraperiosteal injected according to its CE mark.
| Study group | Role | What they receive |
|---|---|---|
| Dermal filler for midface deficit | There will be one group in this study, the actual treatment group. Receives: Device: Dermal filler for midface deficit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (6)
Secondary performance endpoint 1
Response rate based on investigator's midface volume deficit severity scale (MVDSS) assessment.
Measured: 12, 24, 36 and 52 weeks
Secondary performance endpoint 2
Global aesthetic improvement scale (GAIS) grade determined by the investigator.
Measured: 4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 3
Global aesthetic improvement scale (GAIS) grade determined by the subject.
Measured: 4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 4
Subject satisfaction.
Measured: 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.
Measured: 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.
Measured: 4, 12, 24, 36 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start28 Mar 2018
- Primary completion24 Jul 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midface Volume DeficitStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Martin Prinz, Mag., Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532126
- Sponsor's protocol ID
- CPH-401-201331
- Acronym
- PRIMAvera
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2018
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03532126
- Acronym / sponsor ID
- PRIMAvera / CPH-401-201331
- Conditions
- Midface Volume Deficit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermal filler for midface deficit | – | Device: Dermal filler for midface deficitThere will be one group in this study, the actual treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects suffering from moderate to severe midface volume deficit and having healthy skin in the treatment area.
Key inclusion criteria (6 listed)
- Male or female, 18 years of age or older;
- Presence of bilateral, approximately symmetric moderate to severe midface volume deficit, corresponding to MVDSS grades 2-3;
- 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);
- Healthy skin in the midface area and free of diseases that could interfere with evaluation of cutaneous aging or represent a risk for injection;
- 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);
Key exclusion criteria (14 listed)
- Presence or history of hypertrophic scarring, pigment disorders or keloid formation.
- Presence or history of any autoimmune disease or current treatment with immune therapy.
- History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amide-type local anaesthetics.
- Previous treatment with a permanent filler in the area to be treated.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Dermal filler for midface deficitDuring this procedure the device (a dermal filler) will be deep intradermal, subcutaneous or supraperiosteal injected according to its CE mark. | Device | Dermal filler for midface deficit |
Primary outcome
Primary performance endpoint
Time frame: 4 weeks
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.
6 secondary outcomes
Secondary performance endpoint 1
Time frame: 12, 24, 36 and 52 weeks
Secondary performance endpoint 2
Time frame: 4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 3
Time frame: 4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 4
Time frame: 4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 5
Time frame: 4, 12, 24, 36 and 52 weeks
Secondary performance endpoint 6
Time frame: 4, 12, 24, 36 and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Martin Prinz, Mag. study director
Sponsor GmbH
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Midface Volume Deficit, run by Croma-Pharma GmbH at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. 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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary performance endpoint (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.