NCT07331181

Brief Summary

A Post-Market, Single-arm, Confirmatory Interventional Clinical Investigation to evaluate the Performance and Safety of INNEA and INNEA AQUA for the treatment of cheek and décolletage wrinkles

Trial Health

77
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jun 2023Dec 2026

Study Start

First participant enrolled

June 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

July 16, 2024

Last Update Submit

April 13, 2026

Conditions

WrinkleAging

Keywords

wrinklesaging of the skinInnea-2022

Outcome Measures

Primary Outcomes (2)

  • Lemperle Rating scale

    To evaluate the performance of INNEA and INNEA AQUA for the treatment of cheek and décolletage wrinkles after 1 month from the last injection, the lamperle Rating scale will be used: \- The Lemperle Rating Scale (LRS) will be used to assess cheek wrinkles at V4 (1 month after the 3rd injection) by study product.

    1 month after the last injections

  • GAIS for improvement

    The Global Aesthetic Improvement Scale (GAIS) scale will be used to assess improvement of décolletage wrinkles at V4 (1 month after the 3rd injection) by study product.

    One month after the injections

Secondary Outcomes (7)

  • Outcome for performance with Lemperle Rating scale (LRS)

    1 month after the last injections

  • Outcome safety: evaluation of adverse events

    1 month after the last injections

  • Performance with Gais

    1 month after the last injections

  • Performance with Likert scale

    1 month after the last injections

  • Pain intensity evaluation with NRS scale

    1 month after the last injections

  • +2 more secondary outcomes

Other Outcomes (2)

  • Device deficiency

    1 month after the last injections

  • Evaluation during the duration of the study with diary

    1 month after the last injections

Study Arms (1)

Innea

OTHER

At visit 0 after collecting the required informations tha patients will be treat with INNEA or Innea Aqua. Subjects can be treated in one or two of the following areas with one of the two IPs (which will be the same for the three injections planned): * Cheek * Décolletage Performance will be evaluated by the Investigator using the Lemperle Rating Scale (LRS) for cheek wrinkles at each visit, and the Global Aesthetic Improvement Scale (GAIS) for décolletage wrinkles at each post-treatment assessment. In addition, global aesthetic appearance of the face will be assessed through GAIS by the Investigator. Skin radiance and turgor will be evaluated by Subjects using a 5-Likert scale.

Device: Innea, Innea Aqua

Interventions

Innea, Innea AquaDEVICE

INNEA: one syringe contains 2.0 ml of non-pyrogenic gel. The gel is based on the following: sodium hyaluronate 20 mg/ml INNEA AQUA: one syringe contains 2.0 ml of non- pyrogenic gel. The gel is based on sodium hyaluronate 25 mg/ml, trehalose

Innea

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient Informed consent form (ICF) signed;
  • Female Subjects between 35 and 65 years old at the time of the signature of ICF;
  • Subjects with at least 2 (shallow wrinkles) on the Lemperle Rating Scale requiring correction of cheek wrinkles and/or subjects requiring correction of décolletage wrinkles;
  • Willingness to follow all study procedures, including attending all site visits, tests and examinations;
  • Agreeing to present at each study visit without make-up;
  • Willingness not to undergo other procedures involving aesthetic correction (e.g., ultrasound-based treatments, biomaterial implant, lifting, botulinum toxin injections, laser or intense pulsed light treatment, bio-stimulating treatment, chemical peeling, dermabrasion, fillers) during the entire study period;
  • Willingness to follow indications to not be exposed to make-up for 12 hours after injection;
  • Willingness to avoid prolonged exposure to sunlight and UV or using saunas or Turkish baths for one week after the injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ASST degli Spedali Civili di Brescia

Brescia, Brescia, 25123, Italy

RECRUITING

Humanitas Research Hospital

Rozzano, MI, 20089, Italy

RECRUITING

Campus Biomedico

Roma, Roma, Italy

RECRUITING

Study Design

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

Study Record Dates

First Submitted

July 16, 2024

First Posted

January 9, 2026

Study Start

June 1, 2023

Primary Completion

November 30, 2024

Study Completion (Estimated)

December 30, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

IT(3)