Evaluate The Performance And Safety Of The Medical Device Jalucomplex®

NCT04103918 | Completed DMC

• 1 other identifier: OPIRA/0319/MD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and performance of Jalucomplex® dermal filler in terms of absolute change of Wrinkle Severity Rating Scale

  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 Outcomes (5)

• Wrinkles Severity Ranking Scale score assessed by the patient

  84 days

• Global Aesthetic Improvement Scale evaluated by the subject

  84 days

• Treatment satisfaction questionnaire completed by the subject

  84 days

• Investigator Global Assessment of Safety

  84 days

• Patient Global Assessment of Safety

  84 days

Study Arms (1)

Jalucomplex® 2

OTHER

Jalucomplex® 2 (Linear Hyaluronic Acid) Injection: follow the instruction for use

Device: Jalucomplex

Interventions

Jalucomplex DEVICE

Jalucomplex is an injectable intradermal gel containing sodium salts derived from hyaluronic acid.

Jalucomplex® 2

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Use of aspirin and antiplatelet agents a week prior to treatment;
• Pregnant or lactating women;
• Subjects with history of allergy or hypersensitivity to the HA or to other ingredients of the dermal filler;
• Subjects with hypersensitivity to salicylic acid or any of its derivates;
• Subjects with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc.;
• Subjects presenting bleeding disorders in the past or present;
• Hypersensitivity skin reaction to the investigational device based on intradermal test results at baseline.
• Subjects taking or having indications for anticoagulant therapy;
• 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;
• Subjects suffering from infectious diseases including herpes simplex virus infection, active hepatitis or human immunodeficiency virus;
• Subjects suffering from eczema, acne and keloids;
• Subjects with any cutaneous manifested infection, disease or alteration;
• Subjects at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device;
• Subjects with any facial aesthetic surgery in the preceding 12 months before the clinical investigation enrolment;
• Subjects with any active irritation or inflammation in the target areas of injection;

Sponsors & Collaborators

• I.R.A. Istituto Ricerche Applicate S.p.A.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

SCM Dr. Rosu

Timișoara, Timiș County, 300425, Romania

Location

Related Publications (22)

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Study Officials

• Mihaela Frățilă, MD

  SCM Dr. Roșu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: August 24, 2020
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

RO (1)