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RECRUITING
NCT07763990
NA

THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER

Sponsor: Hallura Ltd.

View on ClinicalTrials.gov

Summary

Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be demonstrated based on the responder rates observed compared to baseline.

Official title: PROSPECTIVE, INTERVENTIONAL, NON-RANDOMIZED, OPEN LABEL, BLINDED STUDY FOR THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2023-01-09

Completion Date

2027-01

Last Updated

2026-08-13

Healthy Volunteers

Yes

Interventions

DEVICE

HLR-1

Initial injection of HLR-1 and a touch-up treatment can occur 30 ± 7 days after the initial treatment if the Injector and Subject determine that additional HLR Dermal Filler would improve the aesthetic outcome. The Maximum allowable dose for the touch up treatments is half of initial dose for the whole lips.

DEVICE

HLR-2

Initial injection of HLR-1 and a touch-up treatment can occur 30 ± 7 days after the initial treatment if the Injector and Subject determine that additional HLR Dermal Filler would improve the aesthetic outcome. The Maximum allowable dose for the touch up treatments is half of initial dose by side.

DEVICE

HLR-3

Initial injection of HLR-1 and a touch-up treatment can occur 30 ± 7 days after the initial treatment if the Injector and Subject determine that additional HLR Dermal Filler would improve the aesthetic outcome. The Maximum allowable dose for the touch up treatments is half of initial dose by side.

Locations (2)

Hallura Ltd

Tel Aviv, Israel

Ichilov Medical Center

Tel Aviv, Israel