Last reviewed · How we verify
NCT07109635
Post Market Study of Safety and Performance of RefillHA Volume+ for Facial Soft Tissue Augmentation and Correction of Wrinkles and Folds
trial in Wrinkles Such as Nasolabial Folds in 46 participants. Completed in 18 May 2025.
28 October 2024
Quick facts
| Lead sponsor | Glyance |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 46 |
| Start date | 19 February 2024 |
| Primary completion | 28 October 2024 |
| Estimated completion | 18 May 2025 |
| Sites | 1 location across Israel |
Conditions studied
- Wrinkles Such as Nasolabial Folds — all drugs for Wrinkles Such as Nasolabial Folds →
Sponsor
Glyance — full company profile →
Who can join
18 and older, any sex, with Wrinkles Such as Nasolabial Folds. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07109635
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Glyance trials
Trials by the same sponsor.
- NCT07495865 — Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2 · recruiting
- NCT07329608 — Post Market Non-Interventional Study of Safety and Performance of RefillHA Volume · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07109635 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Glyance
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07109635.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing