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Evaluation of Performance and Safety of KIO015 in Face Tissue Filling

NCT05747690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-09-09

No results posted yet for this study

Summary

The clinical investigation is designed to primarily confirm the performance of KIO015 in improving the GAIS assessment, a subjective parameter, including skin roughness. A non-treated zone (untreated hemi-face) was used as comparator for exact evaluation of the zones between the treated and untreated ones The safety of KIO015 was also evaluated for confirmation of initial data.

For this purpose, 78 healthy subjects were injected in half of the face. In KIO015-PLUM, healthy subjects with signs of cutaneous aging and dehydrated skin on the face received either one or three dermal injections:

* Cohort 1: one intradermal injection session of KIO015 device on M0, to evaluate the effect of a single injection session
* Cohort 2: three intradermal injection sessions of KIO015 device on M0, M1 and M2, to evaluate the effect of 3 injection sessions as performed for state-of-the-art products.

Conditions

  • Skin Quality

Interventions

DEVICE

KIO015

Innovative carboxymethyl chitosan-based biomaterial intended for intradermal injection

Sponsors & Collaborators

  • Kiomed Pharma

    lead INDUSTRY

Principal Investigators

  • Patricia MOREL-MANDRINO, MD · Eurofins Dermscan Pharmascan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2023-05-04
Completion
2024-05-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05747690 on ClinicalTrials.gov