NCT06872359 - Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling | Biotech Hunter

Enrollment

210

Participants

Timeline

Start Date

March 25, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

September 30, 2027

Conditions

Dermal FillersCheek AugmentationLip AugmentationPerioral RhytidsMid-facial Volume Deficit Related to AgingLip EnhancementLip Augmentation and Correction of Perioral RhytidsVolume Deficiency in the Mid-FaceVolume Loss of the JawlineJawline DefinitionContouringMidface Contour DeficienciesNasolabial Fold ImprovementNasolabial Folds CorrectionFacial WrinklesFacial Rhytides

Interventions

DEVICE

KIO017-1

Subcutaneous and/or supraperiostal injections in chin and/or mid-face and/or jawline. One (1) injection session on D0 and one (1) touch-up session on M1. The total volume injected per face and per session will not exceed 8 ml.

DEVICE

KIO017-2

Subcutaneous injections in temples and/or nasolabial folds and/or marionette lines and/or mid-face. One (1) injection session on D0 and one (1) touch-up session on M1. The total volume injected per face and per session will not exceed 8 ml.

DEVICE

KIO017-3

Injections in or around labial mucosa for lip volume and contour and/or intradermal injections in perioral lines. One (1) injection session on D0 and one (1) touch-up session on M1. The total volume injected per face and per session will not exceed 8 ml.

Trial Locations (3)

13594

Eurofins Dermscan Pharmascan, Aix-en-Provence

69100

Eurofins Dermscan Pharmascan, Villeurbanne

80-280

"Centrum Medyczne Tu Sie Leczy", Gdansk