NCT06034522

Brief Summary

Adipearl is an injectable filler intended to be injected subcutaneously in the face.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Nov 2023Nov 2026

First Submitted

Initial submission to the registry

August 21, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 25, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

August 21, 2023

Last Update Submit

September 18, 2025

Conditions

Mid-face Volume Deficiency

Outcome Measures

Primary Outcomes (1)

  • Safety of Investigational Medical Device

    Collection of Injection Site Reactions and Adverse Events during the study.

    Up to 6 months

Study Arms (1)

Face correction with Investigational device

EXPERIMENTAL

Subjects will be injected with the investigational device in the face.

Device: Adipearl

Interventions

AdipearlDEVICE

Injection of the investigational device in the face.

Face correction with Investigational device

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Art Clinic

Stockholm, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 13, 2023

Study Start

November 25, 2023

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)