Status:
COMPLETED
Evaluate The Performance And Safety Of The Medical Device Jalucomplex®
Lead Sponsor:
I.R.A. Istituto Ricerche Applicate S.p.A.
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Wrinkle
Eligibility:
All Genders
35-65 years
Phase:
NA
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 th...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Subjects who received botulinum toxin A injections in the face in the preceding 6 months;
- Subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
- Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04103918
Start Date
August 24 2020
End Date
January 20 2021
Last Update
April 12 2021
Active Locations (1)
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1
SCM Dr. Rosu
Timișoara, Timiș County, Romania, 300425