NCT07329608

Brief Summary

This study designed to evaluate the safety and performance of RefillHA Volume, a dermal filler for facial soft tissue augmentation and correction of facial wrinkles and folds in routine clinical setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

December 29, 2025

Last Update Submit

December 29, 2025

Conditions

Wrinkles

Keywords

wrinkles

Outcome Measures

Primary Outcomes (1)

  • 1. The frequency of reported adverse events (number of participants who experienced each reported adverse event). 2. The severity of reported adverse events (1=mild, 2=moderate, 3=severe)

    Up to 56 weeks after treatment

Study Arms (1)

Subjects over the age of 18

Subjects who are seeking correction of facial wrinkles and folds and/or soft tissue augmentation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects over the age of 18 who are seeking correction of facial wrinkles and folds and/or soft tissue augmentation.

You may qualify if:

  • Adult men and women, over the age of 18, seeking correction of facial wrinkles and folds and/or soft tissue augmentation.
  • Subjects who are willing and able to read, understand and sign informed consent.

You may not qualify if:

  • Subjects with known contraindications to the treatment (as per device IFU).
  • Subjects considered to be unsuitable to participate, in the investigator's opinion, for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glyance Ltd

Lod, 7152026, Israel

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 9, 2026

Study Start

January 25, 2024

Primary Completion

December 22, 2024

Study Completion

May 18, 2025

Last Updated

January 9, 2026

Record last verified: 2025-12

Locations

IL(1)