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Open, Non-Comparative Study To Evaluate The Performance Of The Medical Device JANESSE®

NCT04103125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

  • Wrinkle

Interventions

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 IMD by the Investigator in accordance with the CIP

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • I.R.A. Istituto Ricerche Applicate S.p.A.

    lead NETWORK

Principal Investigators

  • Mihaela Fratila · SCM Dr. Rosu

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2020-12-21
Completion
2020-12-21

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103125 on ClinicalTrials.gov