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NCT04103125
Open, Non-Comparative Study To Evaluate The Performance Of The Medical Device JANESSE®
NA trial testing Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. in Wrinkle in 61 participants. Completed in 21 December 2020.
21 December 2020
Quick facts
| Lead sponsor | I.R.A. Istituto Ricerche Applicate S.p.A. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 61 |
| Start date | 14 July 2020 |
| Primary completion | 21 December 2020 |
| Estimated completion | 21 December 2020 |
| Sites | 1 location across Romania |
Drugs / interventions tested
- Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.
Conditions studied
- Wrinkle — all drugs for Wrinkle →
Sponsor
I.R.A. Istituto Ricerche Applicate S.p.A.
Who can join
Adults 35 to 65, any sex, with Wrinkle. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The hypothesis of this clinical investigation is that in a population of men and women affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will cross-linked hyaluronic acid (Janesse) significantly decrease the appearance of facial wrinkles, results observed after 4, 8 and 12 weeks.
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 NCT04103125
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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- NCT06202274 — Clinical Study to Evaluate the Safety and Efficacy of Candela Technology · NA · active not recruiting
Other I.R.A. Istituto Ricerche Applicate S.p.A. trials
Trials by the same sponsor.
- NCT05239117 — Evaluating the Performance and Safety of the Medical Device Plenhyage® in the Treatment of Dermal Tissue Defects · NA · unknown
- NCT05239130 — Evaluating the Performance and Safety of the Medical Device Auralya® in the Treatment of Facial Dermal Tissue Defects · NA · unknown
- NCT05239156 — Evaluating the Performance and Safety of the Medical Device Janesse in the Treatment of Facial Dermal Tissue Defects · NA · completed
- NCT05206474 — To Evaluate the Performance and Safety of the Medical Device IRADYN in Subjects With Osteoarthritis of the Knee · NA · unknown
- NCT05239351 — Evaluating Performance and Safety of the Medical Device Jalucomplex in the Treatment of Facial and Neck Tissue Defects · 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 NCT04103125 (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 I.R.A. Istituto Ricerche Applicate S.p.A.
- Last refreshed: 10 February 2021
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/NCT04103125.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing