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Post Market Study of Safety and Performance of RefillHA Volume+ for Facial Soft Tissue Augmentation and Correction of Wrinkles and Folds

NCT07109635 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2025-08-07

No results posted yet for this study

Summary

This post market study was designed to collect clinical data regarding the safety and performance of RefillHA Volume+ upon its launch, from patients treated with the product in a routine clinical setting of treatments.

In this study, patients seeking correction of facial wrinkles and folds and/or soft tissue augmentation who are candidates for treatment with RefillHA Volume+ according to its approved use will be offered to participate in the study. Eligible patients who are willing to participate in the study, after signing an informed consent, will be treated with RefillHA Volume+ in the facial regions where correction is requested, subject to the advice of the treating physician and in accordance with the approved use.

After recieving initial treatment, participants will attend 2 to 4 in-clinic follow-up visits, during which they will be eligible to receive additional treatment with RefillHA Volume+ (up to two additional treatments during the follow-up period) if, per treating investigator's opinion, additional treatment is required for better correction or to maintain the results.

Clinical data were collected at all in clinic visits, including standardized facial photographs, pain perception self-assessement was recorded by subjects immediately after treatment. All subjects were asked for details of any Adverse Events (AEs) they had experienced. Subjects were asked to rate aesthetic results and Patient Satisfaction questionnaire at each follow-up visit. Physicians were asked to rate aesthetic results as well and details of the treatment session were recorded.

Conditions

  • Wrinkles Such as Nasolabial Folds

Sponsors & Collaborators

  • Glyance

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2024-10-28
Completion
2025-05-18

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 NCT07109635 on ClinicalTrials.gov