Evaluate The Performance And Safety Of The Medical Device Jalucomplex®

April 9, 2021 updated by: I.R.A. Istituto Ricerche Applicate S.p.A.

Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device Jalucomplex® (Hyaluronic Acid-Dermal Filler) In the Treatment Of Facial And Neck Wrinkles To Obtain Facial Rejuvanation

The Research Question of the present study is the following: in a population of men and women affected by facial and neck wrinkles, will linear hyaluronic acid (Jalucomplex®) significantly decrease the appearance of facial and neck wrinkles, results observed after 12 weeks?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open, non-comparative study for evaluating the performance and safety of the medical device Jalucomplex in the treatment of facial and neck wrinkles.

Similar dermal fillers have been used in several clinical investigations in humans with a good rate of clinical success and good safety profiles.

Jalucomplex®'s acts by increasing tissue volume based on the natural ability of hydrophilic hyaluronic acid molecules to bind to an amount of water far greater than their own weight. This allows the material to fill intra-dermal spaces and supplement the intercellular matrix. Linear hyaluronic acid is a polymer that represents one of the essential components of human skin, subcutaneous and connective tissue; its ability to form complexes with water molecules increases the level of tissue hydration, turgidity and plasticity.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300425
        • SCM Dr. Rosu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men or women with age > 35 and ≤ 65 years.
  2. Subjects with facial and neck wrinkles, seeking tissue augmentation treatment and willing to receive HA Filler;
  3. Subjects presenting a score of 2 (shallow wrinkles) or 3 (moderate, deep wrinkles) on the Wrinkles Severity Ranking Scale (WSRS);
  4. Subjects who agree to discontinue all dermatological treatment and procedures during the study.
  5. Subjects willing to provide signed informed consent to clinical investigation participation.
  6. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.

Exclusion Criteria:

  1. Use of aspirin and antiplatelet agents a week prior to treatment;
  2. Pregnant or lactating women;
  3. Subjects with history of allergy or hypersensitivity to the HA or to other ingredients of the dermal filler;
  4. Subjects with hypersensitivity to salicylic acid or any of its derivates;
  5. Subjects with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc.;
  6. Subjects presenting bleeding disorders in the past or present;
  7. Hypersensitivity skin reaction to the investigational device based on intradermal test results at baseline.
  8. Subjects taking or having indications for anticoagulant therapy;
  9. Use of concomitant treatments or procedures aimed to improve skin rejuvenation over the last six months before the clinical investigation enrolment, such as chemical peeling, dermabrasion, laser resurfacing;
  10. Subjects suffering from infectious diseases including herpes simplex virus infection, active hepatitis or human immunodeficiency virus;
  11. Subjects suffering from eczema, acne and keloids;
  12. Subjects with any cutaneous manifested infection, disease or alteration;
  13. Subjects at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device;
  14. Subjects with any facial aesthetic surgery in the preceding 12 months before the clinical investigation enrolment;
  15. Subjects with any active irritation or inflammation in the target areas of injection;
  16. Subjects who received botulinum toxin A injections in the face in the preceding 6 months;
  17. Subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits.
  18. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
  19. Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Jalucomplex® 2
Jalucomplex® 2 (Linear Hyaluronic Acid) Injection: follow the instruction for use
Device: Jalucomplex
Jalucomplex is an injectable intradermal gel containing sodium salts derived from hyaluronic acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety and performance of Jalucomplex® dermal filler in terms of absolute change of Wrinkle Severity Rating Scale
Time Frame: 84 days
To evaluate the overall safety of the medical device and performance of Jalucomplex® dermal filler in terms of absolute change of Wrinkle Severity Rating Scale score assessed by Investigator at 2, 4, 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0). The Wrinkle Severity Rating Scale has 5 points: 5 extreme, 4 Severe, 3 moderate, 2 minore, 1 absente. A lower value after the administration of IP will signify an improvement in wrinkle condition
84 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wrinkles Severity Ranking Scale score assessed by the patient
Time Frame: 84 days
Wrinkles Severity Ranking Scale score assessed by the patient before and after the injection. The Wrinkle Severity Rating Scale has 5 points: 5 extreme, 4 Severe, 3 moderate, 2 minore, 1 absente. A lower value after the administration of IP will signify an improvement in wrinkle condition.
84 days
Global Aesthetic Improvement Scale evaluated by the subject
Time Frame: 84 days
General appearance after treatment assessed by the subject at 8 and 12 weeks after the first treatment session compared to Baseline Visit (day 0) using the Global Aesthetic Improvement Scale. There are 5 grades on this scale: 1 very much improved, 2 much improved, 3 improved, 4 no change, 5 worse
84 days
Treatment satisfaction questionnaire completed by the subject
Time Frame: 84 days
Treatment satisfaction questionnaire completed by the subject has 3 options: very satisfied, satisfied and not satisfied. A 'Very Satisfied' answer from the patient is considered a very good outcome compared with the lowest grade 'Not Satisfied'
84 days
Investigator Global Assessment of Safety
Time Frame: 84 days
Investigator Global Assessment of Safety (IGAS) - using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety
84 days
Patient Global Assessment of Safety
Time Frame: 84 days
It will be reported by the subject at the last visit using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety.
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Opera CRO, a TIGERMED Group Company

Investigators

  • Principal Investigator: Mihaela Fratila, MD, SCM Dr. Rosu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2020

Primary Completion (Actual)

January 20, 2021

Study Completion (Actual)

January 20, 2021

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • OPIRA/0319/MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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