Clinical trial NCT03532126: A 52-week Clinical Investigation of Princess® VOLUME PLUS Lidocaine in Subjects With Midface Volume Deficit
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Midface Volume Deficit
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: FGK Clinical Research GmbH
First posted: 2018-05-22
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Primary performance endpoint
timeFrame: 4 weeks
Secondary outcomes:
measure: Secondary performance endpoint 1
timeFrame: 12, 24, 36 and 52 weeks
measure: Secondary performance endpoint 2
timeFrame: 4, 12, 24, 36 and 52 weeks
measure: Secondary performance endpoint 3
timeFrame: 4, 12, 24, 36 and 52 weeks
measure: Secondary performance endpoint 4
timeFrame: 4, 12, 24, 36 and 52 weeks
measure: Secondary performance endpoint 5
timeFrame: 4, 12, 24, 36 and 52 weeks
measure: Secondary performance endpoint 6
timeFrame: 4, 12, 24, 36 and 52 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medizinisch Ästhetisches Zentrum Wien
city: Vienna
country: Austria
facility: Yuvell
city: Darmstadt
country: Germany
facility: Rosenpark Research
state: Hessen
city: Berlin
country: Germany
facility: RZANY & HUND, Privatpraxis
Study officials:
affiliation: Sponsor GmbH
name: Martin Prinz, Mag.
role: STUDY_DIRECTOR
References: