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

Midface Volume Deficit Clinical Trial

— PRIMAvera  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532126
• Other study ID #: CPH-401-201331
• Status: Completed
• Start date: March 28, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2021
• Source: Croma-Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 30, 2020
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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). -

Related Conditions & MeSH terms

• Midface Volume Deficit

Intervention

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.

Locations

Country	Name	City	State
Austria	Medizinisch Ästhetisches Zentrum Wien	Vienna
Austria	Yuvell	Vienna
Germany	RZANY & HUND, Privatpraxis	Berlin
Germany	Rosenpark Research	Darmstadt	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Croma-Pharma GmbH	FGK Clinical Research GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary performance endpoint 1	Response rate based on investigator's midface volume deficit severity scale (MVDSS) assessment.	12, 24, 36 and 52 weeks
Secondary	Secondary performance endpoint 2	Global aesthetic improvement scale (GAIS) grade determined by the investigator.	4, 12, 24, 36 and 52 weeks
Secondary	Secondary performance endpoint 3	Global aesthetic improvement scale (GAIS) grade determined by the subject.	4, 12, 24, 36 and 52 weeks
Secondary	Secondary performance endpoint 4	Subject satisfaction.	4, 12, 24, 36 and 52 weeks
Secondary	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	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