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

NCT03532126 | Completed

• 1 other identifier: CPH-401-201331
• Study Type: observational
• Target: 91
• Locations: 2 countries
• Sites: 4

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.

Conditions

Midface Volume Deficit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Secondary performance endpoint 1

  12, 24, 36 and 52 weeks

• Secondary performance endpoint 2

  4, 12, 24, 36 and 52 weeks

• Secondary performance endpoint 3

  4, 12, 24, 36 and 52 weeks

• Secondary performance endpoint 4

  4, 12, 24, 36 and 52 weeks

• Secondary performance endpoint 5

  4, 12, 24, 36 and 52 weeks

Study Arms (1)

Dermal filler for midface deficit

There will be one group in this study, the actual treatment group.

Device: Dermal filler for midface deficit

Interventions

Dermal filler for midface deficit DEVICE

During this procedure the device (a dermal filler) will be deep intradermal, subcutaneous or supraperiosteal injected according to its CE mark.

Dermal filler for midface deficit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Croma-Pharma GmbH: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (4)

Medizinisch Ästhetisches Zentrum Wien

Vienna, 1010, Austria

Location

Yuvell

Vienna, 1010, Austria

Location

Rosenpark Research

Darmstadt, Hesse, 64283, Germany

Location

RZANY & HUND, Privatpraxis

Berlin, 10707, Germany

Location

Study Officials

• Martin Prinz, Mag.

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 22, 2018
• Study Start: March 28, 2018
• Primary Completion: July 24, 2019
• Study Completion: June 30, 2020
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); AU (2)