CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Janessedevice
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/NCT05239156
NCT05239156N/ACompleted
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Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Janesse® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial Dermal Tissue Defects

I.R.A. Istituto Ricerche Applicate S.p.A.·interventional·Posted Feb 14, 2022·Updated Oct 20, 2022

In Brief

A clinical study evaluating Janesse for Cicatrix and 2 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The Research Question of the present study is the following: in a population of men and women presenting facial dermal tissue defects (scars, depressed plaques, and lipodystrophy defects) will cross-linked hyaluronic acid (Janesse®) significantly decrease and / or improve the appearance of these defects, results observed after 4, 8 and 12 weeks?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCicatrix, Lipodystrophy, Plaque
CountriesRomania
CollaboratorsOpera CRO, a TIGERMED Group Company

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 14, 2022
Enrollment StartMar 14, 2022
Primary CompletionSep 13, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.4 years ago

Interventions

Janessedevice

Device: Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. The subjects will receive at baseline the first investigational medical device by the Investigator in accordance with the clinical investigation plan.