Clinical trial NCT04650620: Study to Evaluate the Performance and Safety of the Medical Device Plenhyage®
Official title: Open, Non-comparative Study to Evaluate the Performance and Safety of the Medical Device Plenhyage® (Polymerized Polynucleotides Dermal Filler) in the Correction of Wrinkles and Improving the Skin Tones and Irregularities (Atrophies) of the Skin Surface in Neck, Abdomen, Thighs, and Buttocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Lead sponsor: I.R.A. Istituto Ricerche Applicate S.p.A.
Sponsor class: NETWORK
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2020-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 20 patients will be administered Plenhyage® thin for the treatment of mild wrinkles;

20 patients will be administered Plenhyage® medium for the treatment of moderate wrinkles;

20 patients will be administered Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks
Primary purpose: OTHER

Brief summary: The Research Question of the present study is the following: in a population of men and women affected by face wrinkles and skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks, will Plenhyage® significantly decrease the appearance of treated areas, results observed after 8 and 12 weeks?

Detailed description: Open, non-comparative, interventional, multicenter study with the total number of screened subjects of 66 (60 evaluable subjects +6 potential screening failure):

* 20 patients will be administered Plenhyage® thin for the treatment of mild wrinkles;
* 20 patients will be administered Plenhyage® medium for the treatment of moderate wrinkles;
* 20 patients will be administered Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks;

Eligibility criteria: Inclusion Criteria:

1. Men or women with age ≥ 30 and ≤ 67 years;
2. Subjects presenting a score of 2 (mild facial wrinkles) for Plenhyage® thin, 3 (moderate facial wrinkles) for Plenhyage® medium on the Wrinkles Severity Ranking Scale (WSRS) seeking skin imperfections treatment;
3. Subjects presenting a ANA score \< 5 seeking treatment for defect and irregularities (atrophies) of the skin surface in neck, abdomen, thighs or buttocks for Plenhyage® strong;
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. Subjects with history of allergy or hypersensitivity to polymerized polynucleotides or to other ingredients of the dermal filler or hypersensitivity skin reaction to the investigational device based on intradermal test results at visit 1.
3. Subjects with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc.;
4. Subjects presenting bleeding disorders in the past or present;
5. Subjects taking or having indications for anticoagulant therapy;
6. 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;
7. Subjects suffering from infectious diseases including herpes simplex virus infection, active hepatitis or human immunodeficiency virus;
8. Subjects suffering from eczema, acne and keloids;
9. Subjects with any cutaneous manifested infection, disease or alteration;
10. Subjects at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device;
11. Subjects with any facial aesthetic surgery in the preceding 12 months before the clinical investigation enrolment;
12. Subjects with any active irritation or inflammation in the target areas of injection;
13. Subjects who received botulinum toxin A injections in the face in the preceding 6 months;
14. Subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits;
15. Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception\* during the study, \*Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).
16. Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study.
17. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.

Primary outcomes:
measure: Wrinkle Severity Rating Scale score evaaluated by the Investigator
timeFrame: 12 weeks
measure: Aesthetic Numeric Scale evaluated by the Investigator
timeFrame: 12 weeks
Secondary outcomes:
measure: WSRS score evaluated by the subject
timeFrame: 12 weeks
measure: Global Aesthetic Improvement Scale
timeFrame: 12 weeks
measure: Treatment satisfaction
timeFrame: 12 weeks
measure: Investigator Global Assessment of Performance
timeFrame: 12 weeks
measure: Investigator Global Assessment of Safety
timeFrame: 12 weeks
measure: Patient Global Assessment of Safety
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Timişoara
country: Romania
facility: SCM Dr. Rosu
state: Timis
Study officials:
References: