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NCT06961305: ALMED
A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume Loss
NA trial testing Cross-linked Hyaluronic Acid Gel in Lip Volume Enhancement in 69 participants. Completed in 2 June 2022.
2 June 2022
Quick facts
| Lead sponsor | Institute Hyalual GmbH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 69 |
| Start date | 10 August 2021 |
| Primary completion | 2 June 2022 |
| Estimated completion | 2 June 2022 |
| Sites | 4 locations across Ukraine, Poland |
Drugs / interventions tested
- Cross-linked Hyaluronic Acid Gel
Conditions studied
- Lip Volume Enhancement — all drugs for Lip Volume Enhancement →
- Lip Augmentation — all drugs for Lip Augmentation →
- Aesthetic — all drugs for Aesthetic →
Sponsor
Institute Hyalual GmbH
Who can join
Adults 25 to 70, any sex, with Lip Volume Enhancement or Lip Augmentation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This post-marketing, prospective, multicentre, single-arm, open-label clinical investigation aimed to evaluate the safety, tolerability, and effectiveness of the injectable medical device Alexa Medium (based on cross-linked hyaluronic acid) for the correction of lip volume loss. Participants received one or two injections of the product, and effectiveness was assessed using the Global Aesthetic Improvement Scale (GAIS) and the Medicis Lip Fullness Scale (MLFS). Safety data were collected at each visit. The study demonstrated high effectiveness and safety, with most subjects achieving their personal aesthetic goals.
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 NCT06961305
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Institute Hyalual GmbH trials
Trials by the same sponsor.
- NCT06984419 — Clinical Investigation of the Medical Device "Alexa Volume" for Correction of Midface Volume Loss · NA · completed
- NCT06984432 — Evaluation of a Non-cross-linked Hyaluronic Acid Medical Device ("Electri" and "XELA REDERM") for Improving Facial Skin · NA · 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 NCT06961305 (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 Institute Hyalual GmbH
- Last refreshed: 10 June 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/NCT06961305.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing