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

NCT07763990 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit

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.

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    collaborator OTHER

  • Tel-Aviv Sourasky Medical Center

    collaborator OTHER_GOV

  • Hallura Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Israel

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 NCT07763990 on ClinicalTrials.gov