Study to Evaluate the Performance and Safety of the Medical Device Plenhyage®

NCT ID: NCT04650620

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2021-04-02

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;

Conditions

Wrinkle

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Plenhyage® thin

Plenhyage® thin for the treatment of mild wrinkles;

Group Type: EXPERIMENTAL

Plenhyage® thin

Intervention Type: DEVICE

0.75%

Plenhyage® medium

Plenhyage® medium for the treatment of moderate wrinkles;

Group Type: EXPERIMENTAL

Plenhyage® medium

Intervention Type: DEVICE

2%

Plenhyage® strong

Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks

Group Type: EXPERIMENTAL

Plenhyage® strong

Intervention Type: DEVICE

2.5%

Interventions

Plenhyage® thin

0.75%

Intervention Type: DEVICE

Plenhyage® medium

2%

Intervention Type: DEVICE

Plenhyage® strong

2.5%

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Opera CRO, a TIGERMED Group Company

OTHER

Sponsor Role: collaborator

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

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SCM Dr. Rosu

Timișoara, Timiș County, Romania

Countries

Romania

Other Identifiers

OPIRA/0419/MD

Identifier Type: -

Identifier Source: org_study_id