Evaluation of Safety of Filler Injection in Subcutaneous Tissues

NCT ID: NCT06322043

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2025-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Adipearl is an injectable filler intended to be injected subcutaneously.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Face Volume Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Volume correction with Investigational Device

Subjects will be injected subcutaneously with the Investigational Device to correct volume deficiencies.

Group Type EXPERIMENTAL

Adipearl

Intervention Type DEVICE

Injection of the investigational device in subcutaneous tissue.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adipearl

Injection of the investigational device in subcutaneous tissue.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject having given freely and expressly informed consent;
* Subject deemed by the Investigator to be medically fit for injection of the product;
* Female or male subjects aged 22 to 65 years (inclusive);

Exclusion Criteria

* Pregnant or nursing woman or planning a pregnancy during the study.
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
* Subject participating to another research study.
* Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.
Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Volumina Medical S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Summit Clinic

Crans-Montana, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VM-APFB-1023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Skin Quality Improvement
NCT03097835 COMPLETED PHASE2