CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 61 enrolled
Drug / intervention
Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04103125
NCT04103125N/ACompleted
CompareCT.gov

Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device JANESSE® (Hyaluronic Acid-Dermal Filler) In The Correction Of Facial Wrinkles

I.R.A. Istituto Ricerche Applicate S.p.A.·interventional·Posted Sep 25, 2019·Updated Feb 10, 2021

In Brief

A clinical study evaluating Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. for Wrinkle. Completed, enrolled 61 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWrinkle
CountriesRomania
CollaboratorsOpera CRO, a TIGERMED Group Company

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 25, 2019
Enrollment StartJul 14, 2020
Primary CompletionDec 21, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.8 years ago

Interventions

Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.device

The subjects will receive at baseline the first IMD by the Investigator in accordance with the CIP