NCT05747690

Evaluation of Performance and Safety of KIO015 in Face Tissue Filling

A Randomized, Controlled, Split-Face Study to Evaluate the Clinical Performance and Safety of Intradermal Injection of KIO015 for Tissue Filling in Subjects With Signs of Cutaneous Dehydration on the Face

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Kiomed Pharma · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	KIO015	Innovative carboxymethyl chitosan-based biomaterial intended for intradermal injection

Timeline

• Start date: 2023-01-30
• Primary completion: 2023-05-04
• Completion: 2024-05-02
• First posted: 2023-02-28
• Last updated: 2025-09-09

Locations

1 site across 1 country: France